Senior Clinical Research Associate jobs at Merck

Clinical Site Manager - Southern California Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose: A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant recruitment/retention plans Site Activation/Initiation On-site and remote monitoring Overall site relationship management in collaboration with other sponsor roles that interact with the site Close-out activities Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Essential Job Responsibilities: Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. Develops meaningful site relationships through consistent collaborative communication and engagement. May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site (facilities, staff) for trial conduct. Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. Ensures site non-IMP study supplies are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. Oversees the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures validity and completeness of data collected at trial sites. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

The Sr CRA will be responsible for monitoring clinical studies at the site level ensuring adherence to protocols, timelines, ICH/GCP guidelines, and federal regulations. The Sr CRA will perform site qualification visits, study start-up activities, protocol implementation, on site monitoring, and close out activities as assigned and in accordance with Xeris SOPs and related study monitoring plans. Responsibilities • Serves as a CRA to conduct and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan. • Monitors data, on site and/or remotely (as needed), with a focus on participant safety, data integrity and regulatory compliance. Ensures the validity, correctness, and completeness of clinical data. • Ensures data accuracy, accountability and documentation through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF). • Conducts Investigational Product (IP) review and accountability on site. • Serves as point of escalation for clinical site management and investigator sites. Liaises with the in-house CRA interacting with investigator sites and responsible to support effective communications and resolution of issues. • Maintains routine contact with investigator sites between routine on site monitoring visits. • Identifies, assesses, and resolves issues related to site performance, program risks, data inconsistencies/deviations, quality and compliance. Re-educates investigator sites as required, escalates issues, and ensures implementation of corrective actions. • Ensures all essential documents are complete and in place, filed to the study electronic trial master file (eTMF) and inspection ready. Participates in eTMF QC activities and ensures consistency between ISF and eTMF. • Manages query resolution with investigator sites and data management operations. • Supports centralized risk-based monitoring oversight activities as assigned. • May support the Study Manager to formulate regional monitoring strategy, forecasting of site visits and/or overall clinical monitoring plans. • Provides oversight of CRO activities related to monitoring (when outsourced); may co-monitor with CRO or contracted CRAs. • Supports the maintenance of documentation to clinical systems (Clinical Trial Management Systems [CTMS], electronic data capture [EDC], Interactive Response Technology [IRT], etc.) and related supporting documents (manuals, completion guidelines, etc.) in collaboration with other study team members and/or external vendors as applicable. • May support development and revision of monitoring SOPs, processes, forms, templates, tools, etc. with aim of continual improvement and efficiency. • Supports audits/inspections/inspection readiness activities through collaboration with relevant clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA or external regulatory agencies as applicable. • Performs other tasks or responsibilities as assigned. Qualifications • Bachelor's degree (B.A./B.S.) or equivalent in life sciences or related discipline. • 6+ years' experience as a Clinical Research Associate. • Extensive knowledge of trial oversight activities, GCP/ICH and federal regulations, IRB/EC and Investigator responsibilities. • Familiarity with clinical trial systems (i.e. CTMS, EDC, eTMF, etc.). • Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.). • Ability to work independently and as part of a team. • Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications. • Working Conditions: If employee is Chicago based - this is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office as feasible when not traveling. On-site requirements may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 75%. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $80,000 - $140,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Sr CRA will be responsible for monitoring clinical studies at the site level ensuring adherence to protocols, timelines, ICH/GCP guidelines, and federal regulations. The Sr CRA will perform site qualification visits, study start-up activities, protocol implementation, on site monitoring, and close out activities as assigned and in accordance with Xeris SOPs and related study monitoring plans. **Responsibilities** - Serves as a CRA to conduct and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan. - Monitors data, on site and/or remotely (as needed), with a focus on participant safety, data integrity and regulatory compliance. Ensures the validity, correctness, and completeness of clinical data. - Ensures data accuracy, accountability and documentation through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF). - Conducts Investigational Product (IP) review and accountability on site. - Serves as point of escalation for clinical site management and investigator sites. Liaises with the in-house CRA interacting with investigator sites and responsible to support effective communications and resolution of issues. - Maintains routine contact with investigator sites between routine on site monitoring visits. - Identifies, assesses, and resolves issues related to site performance, program risks, data inconsistencies/deviations, quality and compliance. Re-educates investigator sites as required, escalates issues, and ensures implementation of corrective actions. - Ensures all essential documents are complete and in place, filed to the study electronic trial master file (eTMF) and inspection ready. Participates in eTMF QC activities and ensures consistency between ISF and eTMF. - Manages query resolution with investigator sites and data management operations. - Supports centralized risk-based monitoring oversight activities as assigned. - May support the Study Manager to formulate regional monitoring strategy, forecasting of site visits and/or overall clinical monitoring plans. - Provides oversight of CRO activities related to monitoring (when outsourced); may co-monitor with CRO or contracted CRAs. - Supports the maintenance of documentation to clinical systems (Clinical Trial Management Systems [CTMS], electronic data capture [EDC], Interactive Response Technology [IRT], etc.) and related supporting documents (manuals, completion guidelines, etc.) in collaboration with other study team members and/or external vendors as applicable. - May support development and revision of monitoring SOPs, processes, forms, templates, tools, etc. with aim of continual improvement and efficiency. - Supports audits/inspections/inspection readiness activities through collaboration with relevant clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA or external regulatory agencies as applicable. - Performs other tasks or responsibilities as assigned. **Qualifications** - Bachelor's degree (B.A./B.S.) or equivalent in life sciences or related discipline. - 6+ years' experience as a Clinical Research Associate. - Extensive knowledge of trial oversight activities, GCP/ICH and federal regulations, IRB/EC and Investigator responsibilities. - Familiarity with clinical trial systems (i.e. CTMS, EDC, eTMF, etc.). - Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.). - Ability to work independently and as part of a team. -Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications. - Working Conditions: If employee is Chicago based - this is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office as feasible when not traveling. On-site requirements may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 75%. _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-HYBRID _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $80,000 - $140,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US-IL-Chicago_ **Title** _Senior Clinical Research Associate (CRA)_ **ID** _2025-2205_ **Category** _Clinical Development_ **Type** _Full-Time_

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Clinical Site Manager - Southern California Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose: A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant recruitment/retention plans Site Activation/Initiation On-site and remote monitoring Overall site relationship management in collaboration with other sponsor roles that interact with the site Close-out activities Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Essential Job Responsibilities: Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. Develops meaningful site relationships through consistent collaborative communication and engagement. May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site (facilities, staff) for trial conduct. Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. Ensures site non-IMP study supplies are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. Oversees the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures validity and completeness of data collected at trial sites. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

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. Organization Overview: The Clinical Research Scientist (CRS) will be part of the Cardiometabolic Health (CMH) Global Medical Affairs team, supporting the cardiovascular portfolio. This role contributes to medical, scientific, and strategic initiatives to advance the company's mission in improving patient outcomes. Key Responsibilities: Role includes support to Medical, Legal, and Regulatory (MLR) reviews, brand and medical planning, implementation of medical tactics. Contribute to Global Medical Information, Medical Education, Internal Training, evidence generation and scientific data disclosure and support to Commercial teams. Identify opportunities for secondary /post hoc analyses of clinical trials. Provide input to Integrated Evidence Generation (IEG) process as needed. Partner with commercial teams for specific tactics, medical review of promotional materials. Team member for potential contributions to brand and medical planning and implementing tactics of the plans. Support Medical Education through design, content creation and implementation of tactics Train Medical and other functions on data as needed Support Medical Information through input to cFAQs and other documents. Support Phase 3b-4 and Health Economics and Outcomes Research (HEOR) studies as needed. Job Requirements: Advanced medical related graduate degree, such as: PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10+ years of experience in related scientific field (cardiovascular disease experience strongly preferred.) Additional Preferences: Fluent in English; both written and verbal communications Strong interpersonal, organizational and negotiation skills Ability to influence others (both cross-functionally and within the function) and create a positive working environment Excellent teamwork skills Willing to engage in domestic and international travel to the degree appropriate to support the business of the team. Strong individual leadership skills 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 $177,000 - $308,000 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

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. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. Demonstrate compliance with procedures and be accountable for compliance of team members. Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. Collaborate with Global Patient Safety on risk management planning. Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. Participate in data analysis, scientific dissemination, and preparation of final study reports. Analyze and contextualize clinical data to support decision-making and portfolio strategy. Contribute to strategic planning and innovation through cross-functional working groups. Support planning and execution of symposia, advisory boards, and other external engagements. Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development Stay current with medical literature and scientific developments in breast oncology. Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. Provide scientific consultation to medical affairs, health outcomes, and commercial teams. Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience 3+ years of clinical research scientist experience/clinical trial experience Direct Line Leadership experience Additional Information/Preferences: Breast cancer disease state knowledge/experience An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication 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 $177,000 - $308,000 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

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. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities * Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. * Demonstrate compliance with procedures and be accountable for compliance of team members. * Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. * Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. * Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. * Collaborate with Global Patient Safety on risk management planning. * Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. * Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. * Participate in data analysis, scientific dissemination, and preparation of final study reports. * Analyze and contextualize clinical data to support decision-making and portfolio strategy. * Contribute to strategic planning and innovation through cross-functional working groups. * Support planning and execution of symposia, advisory boards, and other external engagements. * Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. * Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development * Stay current with medical literature and scientific developments in breast oncology. * Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. * Provide scientific consultation to medical affairs, health outcomes, and commercial teams. * Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development * Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. * Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: * PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Direct Line Leadership experience Additional Information/Preferences: * Breast cancer disease state knowledge/experience * An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) * Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. * Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills * Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. * Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. * Fluent in English, verbal and written communication 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 $177,000 - $308,000 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

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. Clinical Research Scientist - Medical Affairs Allergy, Immunology BU Purpose: The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly's R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly's medications. Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The application of scientific and clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral member of the medical affairs team. The Medical Affairs CRS supports the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; 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; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s). The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local and global business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The global team CRS is responsible for collaborating with the global development teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Business/ customer support (pre and post launch support) Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers) Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts. Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan. Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, 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 currently marketed brands. By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. Support training of sales representatives, and other medical representatives. 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 patient advocate, as well as a medical expert supporting identification of Clinical Care Gaps (CCGs). Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service). Understand and apply knowledge of customer insights to all customer-related activities. Participate in local or national trade associations as appropriate. 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 health care professionals. Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff. Prepare or review scientific information in response to customer questions or media requests. Provide follow-up to information requested by health care 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 scientific 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. 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). Support efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams. Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes). Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design. Clinical Research/Trial Execution and Support Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects. 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). Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel. Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Review lIT proposals and publications, as requested. Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams. 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. Regulatory Support Activities Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists. Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective. Participate in advisory committees. Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS). Scientific / Technical Expertise and continued development 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 (3-5 years). 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. Responsible for the scientific training of the clinical study team. Acts 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. Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget. Use knowledge of specific disease states and available treatments to provide scientific and medical input, contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality. Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable. Collaborate proactively and productively with all alliance, business, and vendor partners. Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness. Actively participate in recruitment, diversity, and retention and hiring efforts as applicable. Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management. Model the leadership behaviors. Be an ambassador of both patients and the Lilly Brand. Minimum Qualification Requirements: PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience Clinical trial experience in drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Other Information/Additional Preferences: Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills. Demonstrated strong communication, interpersonal, teamwork, organizational 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. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders Disease advocates and lay organizations focused on relevant health issues Formulary representatives (private and government) Demonstrates the following competencies Making Business Decisions with data - Harnesses the power of data and analytics to solve problems, make good decisions and measure results. Job-Based Skills: Defines the problem or decision to be made within context of strategy or goals/objectives. Identifies relevant sources and validates accuracy of data. Analyzes and synthesizes data and identifies trends. Draws conclusions and makes timely, well-informed decisions. Engages data and analytics colleagues appropriately when needed. Scientific/Information Exchange - Maximizes engagement with key customers and colleagues through the integration of personal and/or non-personal channels when collaborating, discussing, and sharing science/information. Job-Based Skills: Identifies challenges, information gaps, education needs, and delivery preferences. Creates an engaging narrative. Generates content with the channel(s) and medium(s) in mind. Adjusts style and tone to meet the unique needs of each audience. Uses preferred channel(s) to deliver at the time of need. Measures knowledge gained. Technical/Functional Expertise - Leads with technical and functional expertise. Job-Based Skills: Establishes appropriate scientific and medical subject matter expertise (e.g., disease states, therapeutic landscapes, drug development processes, portfolio, etc.). Maintains relevant knowledge of the healthcare landscape (e.g., health, payer, and regulatory systems and processes) and environment (e.g., HCP experience models and patient flow maps, value/accountable care, and population health landscape, etc.). Understands the advancements in technology that are influencing area of expertise and function (i.e., real-world clinical practice, AI techniques, tools and platforms). Develops appropriate knowledge of activities that can be used to influence and deliver on organizational purpose (i.e., shape clinical practice, systems, tools and platforms). Masters individual workstream tools and processes. Strategic Agility - Defines and commits to an initial strategy or approach; monitors effectiveness; and adapts based on new information and/or insights. Job-Based Skills: Develops an actionable strategy or approach-involving colleagues and engaging stakeholders appropriately. Creates a clearly defined measurement plan with key metrics and triggers. Monitors progression and impact against key metrics. Identifies opportunities to improve. Reassesses strategy/approach and pivots when appropriate. 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 $151,500 - $244,200 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

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Operations team in Denmark (candidates can be based anywhere in Denmark). This position will work on a Nordic team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. If you are looking for a stable, consistently, rapidly, developing CRO, Medpace is a great place for you! We are currently seeking full-time, home or office-based Clinical Research Associates to join our energetic Clinical Monitoring team in the Denmark. We offer an exciting career where you can grow further, using your current and and previous expertise. Responsibilities * Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas; * Perform source document verification and case report form review; * Perform regulatory document review; * Conduct study drug inventory; * Perform adverse event and serious adverse event reporting and follow-up; and * Assess patient recruitment and retention. Qualifications * Bachelor of Science in health-related field; * Proven CRA experience of at least 1.5 years independent monitoring experience * Broad knowledge of medical terminology and clinical patient management; * Basic knowledge of drug therapy techniques and clinical research methodologies; * Fluency in local language and excellent English are required. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 50+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks * Flexible work environment * Competitive compensation and benefits package * Competitive PTO packages * Structured career paths with opportunities for professional growth * Company-sponsored employee appreciation events * Employee health and wellness initiatives Awards * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. Key Responsibilities * Responsible for overall quality, maintenance, and completeness of Trial Master Files. * Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. * Develop project specific TMF plan and structure and update the plan as needed. * Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. * Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. * Act as a liaison between the Site IRBs and study team to resolve queries and concerns. * Provide study team reports or updates regarding status of TMF on a regular basis. * Participate in audits and provide documents as requested. * Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. * Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. * Champion best practices for building and maintaining TMF health. Professional Experience / Qualifications * BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings * Knowledge of and direct experience with Trial Master Files. * Prior eTMF (e.g. Veeva) administration required. * Strong Microsoft Office skills required. * Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). * Fundamental knowledge of the conduct of clinical trials is preferred. * Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities * Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. * Demonstrate compliance with procedures and be accountable for compliance of team members. * Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. * Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. * Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. * Collaborate with Global Patient Safety on risk management planning. * Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. * Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. * Participate in data analysis, scientific dissemination, and preparation of final study reports. * Analyze and contextualize clinical data to support decision-making and portfolio strategy. * Contribute to strategic planning and innovation through cross-functional working groups. * Support planning and execution of symposia, advisory boards, and other external engagements. * Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. * Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development * Stay current with medical literature and scientific developments in breast oncology. * Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. * Provide scientific consultation to medical affairs, health outcomes, and commercial teams. * Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development * Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. * Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: * PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Direct Line Leadership experience Additional Information/Preferences: * Breast cancer disease state knowledge/experience * An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) * Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. * Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills * Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. * Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. * Fluent in English, verbal and written communication 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 $177,000 - $308,000 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

Clinical Site Manager - Southern California Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose: A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant recruitment/retention plans Site Activation/Initiation On-site and remote monitoring Overall site relationship management in collaboration with other sponsor roles that interact with the site Close-out activities Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Essential Job Responsibilities: Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. Develops meaningful site relationships through consistent collaborative communication and engagement. May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site (facilities, staff) for trial conduct. Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. Ensures site non-IMP study supplies are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. Oversees the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures validity and completeness of data collected at trial sites. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

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. Job Title: Entry level Research Associate (per diem) Clinical/Data Entry Work Location: onsite in Baltimore, MD (some of the data entry work can be done remotely after training) Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore, MD unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. What you'll do after training is completed (including but not limited): Clinical: You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results Prepare/monitor study supplies and stock levels in clinic/hospital. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Data Entry: Complete Case Report Forms/eCRF's according to sponsor expectations and set documentation standards for staff to follow. Review, monitor and address quality of data entry for accuracy and trends throughout the study. Maintain neat and legible documentation across all Case Report Forms. Review Case Report Forms to confirm capture of data according to protocol and amendments. Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries. Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions. Organize track and report status of data entry to ensure that study data timelines are met. Check, review and ensure timely submission of data clarifications/queries. Your Profile: Proven customer service experience in a fast-paced environment Background working in a medical or clinical setting Comfortable with prolonged periods of standing and walking B.S.+ in related life science field OR HS diploma/GED with relevant experience CPT/Phlebotomy is highly preferred Hours/Shift - please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits) Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift M-F 6:50am to 3:20pm) Minimum availability requirements: 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) Shift Details: Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend) Bi-monthly attendance may be required for training sessions, unless there are no mandatory trainings to complete Base Pay Range: $20.00 to $22.00 per hour (this role is eligible for shift differentials) Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. 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.

Clinical Site Manager - Southern California Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose: A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant recruitment/retention plans Site Activation/Initiation On-site and remote monitoring Overall site relationship management in collaboration with other sponsor roles that interact with the site Close-out activities Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Essential Job Responsibilities: Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. Develops meaningful site relationships through consistent collaborative communication and engagement. May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site (facilities, staff) for trial conduct. Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. Ensures site non-IMP study supplies are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. Oversees the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures validity and completeness of data collected at trial sites. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off