Physician jobs at Octapharma Plasma - 183 jobs

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. Trial Start-Up Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. Contribution to the timely preparation of medically relevant core trial documents and timely milestones. Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, “Information for CRF completion” (ICC), Data Review Plan (e.g., propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. Trial Conduct Ongoing medical review with transparent documentation of the activity, related findings and resolutions. Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. Proactively address/ communicate clinical quality issues in a collaborative environment. Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. Building network with experts and active contribution to site engagement. Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. Medical review of and contribution to the content of Trial Newsletters Contribution to the scientific publication of trial data, if applicable Leadership Management of medical activities related to one or more clinical trials Cross functional planning, execution, and analysis of a clinical program Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes Compliance with Parexel standards Comply with required training curriculum Complete timesheets accurately and timely as required Submit expense reports as required Update CV as required Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements Skills: Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) Proficiency in written and spoken English and (local language) Excellent interpersonal, active listening and influencing skills Pronounced analytical skills and systematic and well-structured working style. Pronounced presentation and training skills Capability to work proactively and with team spirit in an international environment Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment Knowledge and Experience: Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities Understanding of relevant regulations and guidance including ICH-GCP. Experienced with data visualization systems and IT systems. Education: Physician MD, ideally with medical thesis, trained in a clinical setting Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. #LI-LG4 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. **Trial Start-Up** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan. + Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report + Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. **Trial Conduct** + Ongoing medical review with transparent documentation of the activity, related findings and resolutions. + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively address/ communicate clinical quality issues in a collaborative environment. + Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols + Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. + Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM. + Medical review of and contribution to the content of Trial Newsletters + Contribution to the scientific publication of trial data, if applicable **Leadership** + Management of medical activities related to one or more clinical trials + Cross functional planning, execution, and analysis of a clinical program + Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes **Compliance with Parexel standards** + Comply with required training curriculum + Complete timesheets accurately and timely as required + Submit expense reports as required + Update CV as required + Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) + Proficiency in written and spoken English and (local language) + Excellent interpersonal, active listening and influencing skills + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills + Capability to work proactively and with team spirit in an international environment + Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment **Knowledge and Experience** **:** + Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities + Understanding of relevant regulations and guidance including ICH-GCP. + Experienced with data visualization systems and IT systems. **Education:** + Physician MD, ideally with medical thesis, trained in a clinical setting + Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred. \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job DescriptionThe Sleep Disorder Center of Louisiana Who We Are The Sleep Disorder Center of Louisiana is a leading provider of comprehensive sleep health services in Lafayette. We are committed to improving the lives of our patients through expert diagnosis, evidence-based treatment, and compassionate care. Our team is dedicated to advancing the field of sleep medicine while delivering personalized, high-quality care in a collaborative environment. The Role We are seeking a Physician Assistant (PA-C) to join our dynamic team. In this role, you will play a vital part in evaluating, diagnosing, and managing a wide range of sleep disorders. Working closely with our physicians, sleep technologists, and support staff, you will help patients achieve better sleep and overall wellness. Your Impact Comprehensive Evaluations: Conduct detailed patient assessments, including medical histories, physical exams, and sleep-related evaluations. Diagnostic Insight: Interpret sleep studies such as polysomnography and home sleep apnea tests to guide clinical decisions. Collaborative Care Planning: Work alongside physicians to develop accurate diagnoses and individualized treatment plans. Treatment Management: Implement and monitor treatment strategies, manage medications, and educate patients on sleep hygiene and lifestyle modifications. Continuity of Care: Provide follow-up care, adjust treatments as needed, and coordinate referrals while maintaining thorough documentation. Patient-Centered Approach: Deliver empathetic, patient-focused care and support patients and their families throughout their treatment journey. Who You Are Licensed as a Physician Assistant in the state of Louisiana (or eligible for licensure). Experience in sleep medicine is a plus but not required. Strong clinical assessment and diagnostic skills. Excellent communication and interpersonal abilities. Passionate about delivering patient-centered care. A collaborative team player who thrives in a multidisciplinary setting. Why Join Us? Competitive compensation Opportunities for professional growth and development Supportive, team-oriented work environment Be part of a respected and innovative sleep medicine practice in Louisiana Join Our Team at The Sleep Disorder Center of Louisiana!

Seeking a dedicated, intelligent, and focused Family Physician to be a part of our team. Established in 1993, Heart City Health takes a multifaceted approach and is highly focused on “wholehearted healthcare”. We are a 501 (c)(3) non-profit Federally Qualified Health Center (FQHC) committed to providing and enhancing healthcare services and have a vision to transform healthcare by improving access, service, quality and efficiency and support the goal of a healthier community. In tandem with this commitment is the focus of clinical teams to provide compassionate, patient-centered care to every patient, every time. With health disparities being a major concern for our patients in Elkhart, Indiana, our ideal candidate is a bright, energetic, culturally sensitive and talented physician who wants to make a difference. Qualifications Current Indiana License and valid CSR/DEA required. Board Certified in Family Medicine - If board eligible, must be within 4 years of residency and planning to take boards within two years. Bilingual (English and Spanish) preferred. Acceptable Claims History. Benefits Malpractice insurance covered by HCH and the FTCA, medical, dental, and vision insurance. Company-paid Life, STD, and LTD insurance. Supplemental insurances offered, PTO, EAP, ten (10) paid holidays, 403(b) w/ matching, bonus potential, continuing education allowance and paid time, employee recognition programs and rewards, relocation assistance and more! Responsibilities Responsibilities include obtaining medical and social history of patients, performing systematic physical examinations, and accurately interpreting lab data and other supporting information for diagnosis and treatment of acute and chronic disease.The provider will appropriately code patient visits and prescribe medications, accurately document patient data, diagnosis, and treatment plans, and initiate medical and social referrals as indicated. Multiple Locations around Elkhart! Benefits: Dental insurance Employee assistance program Employee discount Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Professional development assistance Referral program Relocation assistance Retirement plan Tuition reimbursement Vision insurance Medical specialties: Internal Medicine Ob/Gyn Pediatrics Primary Care Urgent Care Schedule: Day shift Monday to Friday

Seeking a dedicated, intelligent, and focused Family Physician to be a part of our team. Established in 1993, Heart City Health takes a multifaceted approach and is highly focused on "wholehearted healthcare". We are a 501 (c)(3) non-profit Federally Qualified Health Center (FQHC) committed to providing and enhancing healthcare services and have a vision to transform healthcare by improving access, service, quality and efficiency and support the goal of a healthier community. In tandem with this commitment is the focus of clinical teams to provide compassionate, patient-centered care to every patient, every time. With health disparities being a major concern for our patients in Elkhart, Indiana, our ideal candidate is a bright, energetic, culturally sensitive and talented physician who wants to make a difference. Qualifications Current Indiana License and valid CSR/DEA required. Board Certified in Family Medicine - If board eligible, must be within 4 years of residency and planning to take boards within two years. Bilingual (English and Spanish) preferred. Acceptable Claims History. Benefits Malpractice insurance covered by HCH and the FTCA, medical, dental, and vision insurance. Company-paid Life, STD, and LTD insurance. Supplemental insurances offered, PTO, EAP, ten (10) paid holidays, 403(b) w/ matching, bonus potential, continuing education allowance and paid time, employee recognition programs and rewards, relocation assistance and more! Responsibilities Responsibilities include obtaining medical and social history of patients, performing systematic physical examinations, and accurately interpreting lab data and other supporting information for diagnosis and treatment of acute and chronic disease. The provider will appropriately code patient visits and prescribe medications, accurately document patient data, diagnosis, and treatment plans, and initiate medical and social referrals as indicated. Multiple Locations around Elkhart! Benefits: * Dental insurance * Employee assistance program * Employee discount * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Professional development assistance * Referral program * Relocation assistance * Retirement plan * Tuition reimbursement * Vision insurance Medical specialties: * Internal Medicine * Ob/Gyn * Pediatrics * Primary Care * Urgent Care Schedule: * Day shift * Monday to Friday

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Purpose: Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource and leader for study teams, departments, and others as needed. The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision. Responsibilities: The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. General Responsibilities Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget. Actively set and meet individual professional development goals and contribute to the development of others. Actively participate in recruitment, diversity, and retention efforts. Collaborate proactively and productively with all alliance, business and vendor partners. Participate in active coaching by providing timely and constructive feedback to co-worker, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness. Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management. Ensures that at all times is adequately qualified and trained in the tasks required to perform Includes accountability and compliance for maintaining a current curriculum training map for self. Model leadership behaviors. Serve as an ambassador of both patients and the LillyBrand. Clinical Planning Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design. Contribute to business unit and global alignment of clinical strategy and clinical plans. Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Clinical Research/Trial Execution and Support. Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports)according to the agreed upon project timeline. Provide oversight and input into ICDs. Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). Review and approve risk profilesto ensure appropriate communication of risk to study subjects. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical operations personnel/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. Review IIT proposals and publications, as requested by Director-Medical. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external healthcare professionals. Understand and actively address the unsolicited scientific information needs of external healthcare professionals according to guidelines above. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with healthcare professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Prepare or review scientific information in response to customer questions or media requests Provide telephone follow-up or specific written information requested by healthcare professionals as per global SOPs. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Support the design of customer research as medical expert. Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel. Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications. Regulatory Support Activities Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal. Provide medical expertise to regulatory scientists. Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective. Participate in advisory committees. Participate in risk management planning along with affiliates and Global Patient Safety(GPS). Business/ Customer Cupport Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans personnel and other cross-functional management during the development of the local business plan. Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers). Actively address Development customer (payer, patient, and healthcare providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts. Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization. Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for the brand. By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed. Become familiar with market archetypes and potential influence on the medical interventions for the product. Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert. Participate in PhRMA or other local or national trade associations. Scientific /Technical Expertise and continued development Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5years). Responsible for the scientific training of the clinical study team. Act as scientific consultant and protocol expert for clinical study team members and others in medical. Explore and take advantage of opportunities for extramural scientific experiences. Minimum Qualification Requirements: Medical Doctor. US trained physicians must have achieved board eligibility or certification. Must be board-eligible or certified in one of the following: Endocrinology or Internal Medicine Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see******************************* Fluent in English; both written and verbal communications. Minimum of two years clinical experience in Endocrinology or Internal Medicine with experience in metabolic disorders. Minimum of five years research in metabolic disorders. Other Information/Additional Preferences: Location flexible but must be able to work EST standard business hours with hybrid team headquartered in Indianapolis Demonstrated knowledge of drug development process, including clinical, regulatory, and operational aspects Has clinical development experience in an industry setting, including clinical trial design, medical monitoring, data interpretation, and/or regulatory principles/ submissions Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills. Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $356,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly