Clinical research associate jobs in Manchester, NH

The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development at Alkermes. He/She will lead operations across all future clinical sites to ensure operational and the organization's objectives are met. The candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance. Role and Responsibilities Responsible for developing strategy, and methodology of clinical operations programs. Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready. Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals. Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines. Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers). Ensures timely execution excellence input into various documents, incl asset evidence plan and clinical trial protocols. Responsible for collaborating with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable. Drive site selection and subject recruitment programs to deliver study enrollment targets. Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors. Participates in SOP development, process mapping, training of CTAs, and other departmental activities. Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs Minimum Education & Experience Requirements: M.S or Ph.D in basic sciences with 10+ years' experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO. Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience leading global trials outside the US/UE/ASIA/Americas is preferred. Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management. Demonstrated experience in successful planning and implementation of clinical trial operations. Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. Required / Desired 5+ years of experience in clinical trials

Clinical Trial Manager - Phase 1 Studies Contract Role Our client's Early Clinical Stage Development team is seeking an experienced Clinical Trial Manager (CTM) to lead Phase 1 clinical trial operations. This role plays a central part in advancing early-stage clinical programs and ensuring high-quality, inspection-ready execution across all clinical sites. The CTM will provide end-to-end operational leadership, including strategy development, trial planning, vendor oversight, budget management, and proactive risk mitigation to ensure on-time, compliant delivery of Phase 1 studies. Key Responsibilities Develop and implement strategy, methodology, and operational plans for clinical programs. Ensure all clinical trials are conducted in full compliance with regulatory requirements and are consistently inspection-ready. Lead the planning, oversight, and execution of Phase 1 studies-from Start of Development through Proof of Clinical Concept. Manage trial budgets, timelines, and operational deliverables in accordance with ICH-GCP and applicable global regulations. Provide operational and strategic input on training materials, program standards, clinical development plans, and regulatory documents (e.g., Investigator Brochure, CSR, safety updates, briefing books, submission content). Drive execution excellence and contribute to trial protocols, asset evidence plans, and other development documents. Collaborate with the Clinical Trial Supply Unit to determine comparator sourcing strategies as needed. Lead site selection, startup activities, and recruitment strategies to meet enrollment goals. Participate in database setup, UAT testing, and development of monitoring guidelines, edit checks, and data cleaning workflows. Support departmental activities including SOP development, process mapping, and training of Clinical Trial Assistants. Serve as a key liaison with global cross-functional stakeholders including project management, regulatory affairs, and technical function leads. Minimum Qualifications M.S. or Ph.D. in a scientific discipline with 10+ years of Clinical Operations experience in biotech, pharma, or CRO environments. Strong ability to identify and champion process improvements focused on efficiency, reliability, cost, and quality. In-depth knowledge of FDA/EMEA regulations, ICH guidelines, and GCP requirements. Experience leading global clinical trials; international trial oversight experience preferred. Advanced expertise in patient recruitment, compliance management, safety oversight, document control, investigational product management, and budget administration. Demonstrated success in planning and executing clinical trial operations across all phases. Experience developing protocols, SOPs, CSRs, and regulatory-supporting documentation for NDAs. Proven track record of driving business process transformation and leading cross-functional teams toward complex deliverables.

Lead operations across clinical sites to meet trial objectives. Develop strategy and methodology for clinical operations programs. Ensure clinical trials comply with regulatory requirements and are inspection-ready. Plan, oversee, and deliver clinical programs from development to proof of concept. Manage budgets and timelines in accordance with regional regulations and ICH-GCP guidelines. Provide operational and strategic input on training materials and development plans. Oversee vendor selection and ensure effective vendor management. Identify and manage risks to ensure high-quality trial delivery. Ensure investigational product oversight and document management. Lead patient recruitment efforts and ensure safety compliance.

UpTrials is a new platform that helps professionals like yourself get hired faster for relevant clinical research roles. We are partnered with an organization seeking a Clinical Research Coordinator II to join our team onsite in Boston, Massachusetts! To be considered for this and other roles, please create a profile at app.uptrials.com Job Title: Clinical Research Coordinator II Location: Nashua, NH Overview: Our site partner is actively seeking a qualified and driven Clinical Research Coordinator II to support and manage clinical trials across multiple sites. This role requires a hands-on, adaptable professional with strong clinical research experience, especially in the management of all aspects of trial operations and stakeholders, including PIs, patients, and sponsor/CRO representatives. The position will involve regular travel between our partners locations and satellite sites within the company. Key Responsibilities: Coordinate day-to-day activities for clinical research studies across various therapeutic areas (including, but not limited to, ophthalmology, dermatology, pulmonology), and at both at HQ and satellite site locations Perform direct patient-facing duties, including informed consent, visit scheduling, and follow-up Manage all aspects of patient recruitment and enrollment across studies, including database reviews, outreach, pre-screening, and communications Confidently perform blood draws and handle biospecimen processing and shipping in accordance with protocol requirements Maintain and manage study documentation, source data, and regulatory binders across numerous systems, including our partner's CTMS, sponsor EDC systems, and more Support monitoring visits and participate in both internal and external audits Communicate effectively with sponsors, CROs, investigators, and internal departments Provide general support to the team and step in across functions as needed to meet study goals Required Qualifications: Minimum 3 years of direct clinical research experience for industry-sponsored, interventional clinical trials for investigational drugs Ability to communicate strongly with patients and gain their trust in efforts to recruit and retain participants throughout the entirety of a study Proficiency in patient care, recruitment, lab specimen handling, monitoring, and auditing Excellent multitasking, time management, and organizational abilities Willingness and ability to travel regularly (up to 50%) across sites Preferred Qualifications: Phlebotomy license or willingness to complete phlebotomy course and obtain licensure Fluent in Spanish (spoken and written) Prior experience with multi-site clinical trials or decentralized trial models Familiarity with clinical trial management systems (CTMS) and electronic regulatory platforms Background in therapeutic areas such as Ophthalmology, Dermatology, or Pulmonology Flexibility, initiative, and a team-oriented mindset are essential Candidates must be comfortable working in a fast-paced, high-accountability environment We believe that the unique contributions of all our site partner's employees are the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the Clinical Project Manager(s). The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. The CRA performs work within established protocols under general supervision. Assists the study team(s) to deliver the clinical study within agreed timelines. Assists in authoring/contributing to clinical study documents and study related plans developed by -Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.) Provides oversight of Clinical CRO Investigator background checks. Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary. Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP. Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items. Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager. Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System. Assists and/or participates in planning and conduct of Investigator's Meetings as necessary. Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced. Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager. Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present. Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements. Assists study team with preparation for audits/inspections Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager. Liaises with Transparency group to ensure Clintrials.gov is updated. Qualifications Requirements: Responsible for assisting and providing support to the members of the clinical operations Study team. The Clinical Trial Coordinator assists in the conduct of trials and will be responsible for managing CRO/Vendor contract and invoice activity. The Clinical Trial Coordinator performs work within established protocols under general supervision. Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor). Experience with finances, accounting or invoicing a plus. Additional Information Kind Regards, Sasha Sharma Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - 732-662-7964

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary Job Description ROLE The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. KEY RESPONSABILITIES Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Conducts investigational product accountability. Reviews regulatory binder for required documents. Works closely with in-house CRAs and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Manages and resolves conflicting priorities to deliver on commitments. Complies with ICH GCP guidelines, FDA regulations, and company SOPs. Participates in industry and client meetings. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE BS/BA from an undergraduate program or equivalent experience 2 years of clinical research experience TECHNICAL COMPETENCES & SOFT SKILLS Ability to travel. Proven ability to be careful, thorough, and detail-oriented. Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. Self-starter who thrives in a collaborative, yet less structured team environment Ability to problem-solve unstructured or ambiguous challenges. Strong command of English, both written and verbal. Excellent communication and interpersonal skills with customer service orientation. Proficient with MS Office Suite, particularly Word and Excel. Permanent authorization to work in the country where you are applying. Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular

Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. Collaborating with investigators and site staff to facilitate smooth study conduct. Performing data review and resolution of queries to maintain high-quality clinical data. Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile Bachelor's degree in a scientific or healthcare-related field highly preferred. Minimum of 2 years of experience as a Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills, with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. Collaborating with investigators and site staff to facilitate smooth study conduct. Performing data review and resolution of queries to maintain high-quality clinical data. Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile Bachelor's degree in a scientific or healthcare-related field highly preferred. Minimum of 2 years of experience as a Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills, with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Job Description Are you passionate about clinical research and ready to make an impact on patients' lives? We're looking for a Clinical Research Associate (CRA) to join a fast-growing biotech company (confidential) that's advancing innovative therapies in neuroscience. What You'll Do: Conduct site initiation, monitoring, and close-out visits to ensure trials meet the highest quality standards. Review and verify study data for accuracy and completeness. Collaborate with site staff and cross-functional teams to solve challenges and keep trials on track. Identify and escalate any protocol deviations, safety concerns, or data issues. Requirements What We're Looking For: Bachelor's in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus). 3+ years of CRA or site monitoring experience. Strong knowledge of ICH-GCP and FDA regulations. Excellent communication, organization, and problem-solving skills. Willingness to travel as needed (up to 50-75%). Extra Credit: Experience with CNS or rare-disease trials. Benefits Amazing benefits package starting day one!

Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field highly preferred. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Clinical Research Associate needs 2-5 years of clinical research experience in industry settings with a bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field Clinical Research Associate requires; oncology experience strongly preferred EDC systems Knowledge of clinical trial methodology as well as the drug research and development process Knowledge of GCP/ICH Guidelines for clinical studies ORACLE CLINICAL TRIALS CLINICAL MONITORING Clinical Research Associate duties are: Participation in the evaluation of clinical trial site locations. Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out. Traveling to sites as necessary to conduct site qualification, initiation, and close-out ( Collecting and managing regulatory documentation, to ensure compliance with GCP, ICH, regulatory authority, and ethics board requirements. Working with clinical site staff and investigators to obtain study data, ensure protocol compliance, and guarantee patient safety. Ensuring accurate and timely reporting of patient safety issues according to all relevant local and federal requirements. Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials. Reviewing incoming clinical data, and preparing reports and presentations on the status of clinical studies. Helping to draft study manuals and protocol amendments as needed. Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials. Coordinating the movement of laboratory samples between clinical sites and central laboratories, and tracking the status of samples and resulting laboratory data. Additional Information $31/HR 6 months

• Requires Bachelors degree from accredited US College or University can NOT be remote, no relocation • This is a 6 month contract - may be extended but not guaranteed • Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) • Experience with finances, accounting or invoicing a plus Qualifications • Requires Bachelors degree from accredited US College or University Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) Additional Information All your information will be kept confidential according to EEO guidelines.

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.

**This is Part-Time; 24 hours/week role** Under direct supervision of the Senior Clinical Research Accounts Specialist, the Clinical Research Accounting Coordinator is responsible for accounts creation and accounts receivable of financial transactions generated from Dana-Farber Cancer Institute Clinical Research activity. Handles basic issues and problems and refers more complex issues to higher -level staff. In the absence of a Senior Clinical Research Accounts Specialist this position is under direct supervision of the Clinical Research Accounting Manager. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. + Submits study financial account creation requests for each new Clinical Research contract budget in a timely manner, as necessary. + Maintains master list of study account numbers with applicable study IRB numbers for tracking and reporting purpose. + Maintains an updated list of payment contacts for all studies and funding sources, as applicable. + Monitors study payment activity and consistently pursues collections from extramural research sponsors and funding sources on all open accounts receivables to ensure timely payments. + Tracks, documents, and reports payment collection follow up with study funding sources while maintaining accurate and organized accounts receivable files. + Organizes and maintains the Clinical Research Accounting central e-mailbox; Responds to study accounts receivable and payment status inquiries via e-mail communications. + Receives Clinical Research checks and wire payments; identifies and enters payments received to the correct study record in the Clinical Trial Management System (CTMS); Stores copies of all payments received for financial reconciliation purpose; submits payments to Finance for study account deposit. + Prepares accounts receivable and other financial reports, forecasts, and analyses, as instructed. + Handles basic issues and problems and refers more complex issues to higher level Clinical Research Accounting team members; escalates invoice revision and justification requests to the applicable Clinical Research Accounting Specialist. + High school diploma required + Bachelor's degree in accounting or finance preferred + MCA Certification within 1-year of hire + No experience required + Working knowledge of the clinical trials lifecycle preferred **KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:** + Effective oral and written communication skills. + Good listening skills. + Ability to perform basic math and accounting skills + Strong organization skills and attention to detail. + Proficiency in data entry and Microsoft Office Suite (especially Excel) + Ability to analyze and interpret financial data accurately + Beginning to working knowledge of basic, financial, tax and accounting principles + Good customer orientation skills **Pay Transparency Statement** The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA) $24.42-28.56/hr At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. **EEOC Poster**

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary The Clinical Research Assistant II (CRA II), to be based in the Osher Center's Mind-Body-Movement Laboratory, will work directly with the Principal Investigator (PI) and Director of the Osher Center for Integrative Health to advance the Center by performing a variety of tasks. The Center is based in the Division of Preventive Medicine at Brigham and Women's Hospital. The CRA II will play an integral role in two ongoing projects in integrative health research: Qualifications 1. Acupoint Sensitization in Inflammatory Bowel Disease (IBD): This is a clinical and translational (C/T) study aimed at addressing knowledge gaps surrounding the biology and scientific basis of acupoints. Based on prior preclinical studies demonstrating cutaneous sensitization or neurogenic inflammation at specific acupoint locations in animal models of colitis, we aim to translate these findings in humans subjects by investigating cutaneous (acupoint) sensitization in IBD. Specific to this project, the CRA II will assist with: * Conducting laser speckle contrast imaging (LSCI) and infrared thermography to measure cutaneous blood perfusion and temperature, respectively * Performing pressure pain threshold (PPT) assessments * Coordinating the collection and storage of biospecimens, including stool and blood samples 2. Effect of Photobiomodulation (PBM) on Stress Physiology: This is a sham-controlled, within-subjects clinical study aimed at evaluating whether or how PBM, a light-based therapy, affects heart rate variability (HRV) under acute stress. Specific to this project, the CRA II will assist with: * Setting up and conducting clinical evaluations, including the stress test, and the delivery of PBM or sham intervention * Collecting HRV and other physiological data (e.g., electrodermal activity, blood pressure) Additional Job Details (if applicable) GENERAL DUTIES AND RESPONSIBILITIES: * Assist with recruitment and enrollment of study participants. * Administer phone screens and assess potential participants' eligibility for inclusion in the study via screening forms and checklists. * Collect in-person informed consent and oversee enrollment process that follows. * Interact with participants prior to enrollment and maintain communication/compliance throughout study life-cycle. * Actively participate in data collection, including administering questionnaires and collecting biological samples and physiological data. * Develop and pilot-test data collection forms and procedures (hardcopy and/or electronic databases, etc.) * Directly respond to inquiries regarding study protocol and policy. Serve as liaison or point-person for the study. * Communicate with the PI concerning appropriate issues during interaction with participants. * Plan agendas and provide logistical support for meetings with study teams. * Collaborate on manuscripts for peer-reviewed journals, including co-authorship of papers. * Participate in decisions made for the study and formulation of study-specific policies and procedures. Identify modifications needed and work to implement solutions. * Performs all other duties, as assigned. SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: * Ability to work well in a team, as well as independently. * Ability to organize and prioritize multiple tasks, and set deadlines. * Excellent interpersonal, oral, and written communication skills. * Careful attention to detail. * Computer literacy and word processing skills. * Ability to demonstrate professionalism and respect for subjects rights and individual needs. * Ability to manage and maintain accurate records across several ongoing projects. * Comfort with technology and ability to learn new research tools and devices; all necessary training will be provided. HOSPITAL WIDE RESPONSIBILITIES: Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH/Mass General Brigham (MGB); follows safe practices required for the position; complies with appropriate BWH and MGB policies and procedures; fulfills any training required by BWH and/or MGB, as appropriate; brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff. Remote Type Hybrid Work Location 900 Commonwealth Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $23.80 - $34.81/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA and AL. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines. The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs. Key ResponsibilitiesIn collaboration with other members of the clinical research site team works to ensure the execution of assigned studies. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; o Filing SAE/Deviation reports to Sponsor and IRB as needed;o Documenting and reporting adverse events;o Reporting non-compliance to appropriate staff in timely manner;o Maintaining positive and effective communication with clients and team members;o Always practicing ALCOAC principles with all documentation; Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.; Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed; Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed; Assist with training of new research assistants and coordinators; Assist with scheduling and planning for visit capacity for assigned studies; May set up, train and maintain all technology needed for studies; May assist with study recruitment, patient enrollment, and tracking as needed; May handle more complex study assignments and volumes; May participate in community outreach / education events; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential AND 1+ years of clinical research coordination experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. CCRC or CCRP credential and BLS certification preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm); Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc Strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team! Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours. This role offers: A great work/life balance No weekends or evenings - Monday thru Friday Paid holidays and paid time off Rapidity growing team with opportunities for advancement Competitive compensation Benefits package Duties you will be responsible for: General Administrative Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. Assists Principal Investigator to assure that all key personnel or persons ‘engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors. Protocol Preparation & Review Attends investigator meetings as required or requested by the PI. Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials. Conduct of Research Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals. Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion. Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source. Coordinates participant tests and procedures. Collects data as required by the protocol. Assures timely completion of Source Documents. Maintains study timelines. Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability. Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures. Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study. Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management. Project Closeout Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures. Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer. Minimum Requirements Clinical research experience preferred Previous phlebotomy skills High School Diploma Interested in learning more? Click here to learn more about the location. Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees. Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law. We thank you for your interest in joining our growing Gastro Health team!

Clinical Research Assistant Needed The role involves monitoring participants using various technology products, collecting data, and ensuring the proper functioning of devices and data collection throughout the study sessions. Great opportunity to gain experience in clinical research! Schedule: * Monday - Friday * 7:30am-3:00pm or 2:00pm-9:00pm *can be flexible* Responsibilities * Consent participants according to protocol and take necessary vitals and measurements (height, weight, EKG) throughout the session. * Ensure participants are properly set up with devices and any monitoring equipment. * Operate several pieces of instrumentation and observe participants using devices during various activities as per protocol. * Ensure data monitoring is functioning properly throughout the session and ensure proper data collection. * Guide participants through the study and support data collection directly. Required Skills * Experience in research and data entry. * Bachelor's Degree in science, exercise science, kinesiology, or biology. * Technical proficiency to operate test devices and perform data entry. * Ability to direct participants through the study, with examples of patient care or people interaction. "Nice to have" Qualifications * Experience in human subject research and data analysis. * Familiarity with gym equipment and clinical research. Pay and Benefits The pay range for this position is $25.00 - $25.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Natick,MA. Application Deadline This position is anticipated to close on Apr 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

ICON has opened a Senior Global Clinical Trial Manager position, and I wanted to see if you are interested. This position will be, direct hire with full benefits, 3 days in the office (900 Winter St, Waltham, MA 02451) with 2 days remote from home, with pay up to $155k (No bonus) Please let me know if you are interested in finding out more about this opportunity? Senior Global Clinical Trial Manager What you will be doing: Clinical Trial Management with, deliverable, budget, vendor management, along with vendor and site oversite and training. Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation. Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight. Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance. Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines. Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary. Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. Your profile: Currently, or recently, working at a CRO, Pharmaceutical or Biotechnology company. A minimum of 4+ years of experience in a Global Clinical Trial Management position at a CRO or Pharmaceutical Organization. Clinical Trial Management experience including trial deliverable, trial budget, vendor management, along with vendor and site oversite and training. Experience as a Clinical Trial Manager running Phase 1 trials Bachelor's degree in health, life sciences, or other relevant fields of study. At least 10+ years of relevant clinical experience Preferred: 2+ years of monitoring experience. Experience in managing complex or global trials is advantageous. Experience in managing trial components from start-up to database lock. Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives.