Clinical Trial Manager / Associate Clinical Trial Manager

Boston1d ago

Seniority: Junior

About the role

ClinChoice is seeking a Clinical Trial Manager / Associate Clinical Trial Manager to join one of our sponsor partners, a Boston-based biotech company focused on CNS disorders. This is a direct-hire, hybrid position requiring three days per week in the office. In this role, you will partner closely with Clinical Operations leadership to support the planning and execution of global clinical trials across multiple indications. It is a highly visible, hands-on opportunity with significant impact on study delivery and operational success. The ideal candidate will have 5+ years of clinical operations experience in biotech or pharma, with a strong background managing outsourced global Phase I–III clinical trials and supporting study start-up activities. They will be highly organized, collaborative professional with expertise in CRO/vendor oversight, trial execution, GCP compliance, and cross-functional coordination to support the successful delivery of a global Phase III study. ClinChoice is a global full-service CRO with a strong focus on quality and professional development. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts.    Main Job Tasks and Responsibilities: <ul> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide support to the Clinical Operations Lead (COL) in the planning, execution, and oversight of a global phase 3 clinical trial from study start-up to close-out.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support the development, review and tracking of study-related documents (protocols, ICFs, investigative brochure, monitoring visit reports, etc.) with cross functional team collaboration.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support start-up activities to help accelerate country and site activations.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Maintain and organize trial documentation (e.g., TMF/eTMF oversight, trackers, meeting minutes) ensuring that study documentation is in a continuous state of inspection readiness.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Contribute to inspection readiness activities and ensure compliance with GCP and SOPs.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Help identify and resolve site risks and/or issues to foster positive site relationships.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Coordinate internal team meetings and participate in cross-functional study meetings.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Proactively communicate study updates with key internal and external stakeholders.</li> </ul>  Education, Experience and Skills:  The Application Process <ul> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Bachelor’s degree is preferably in life sciences or healthcare related field.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">5+ years of clinical operations experience within the biotech or pharma industry required</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience managing outsourced global clinical trials across Phase I–III.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Prior involvement in study start-up activities strongly preferred</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Solid understanding of GCP, ICH guidelines, and the clinical development process.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Experience with clinical trial management systems (CTMS), eTMF, and other operational tools.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ability to multitask and flex across projects as priorities and deadlines shift.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Highly organized with excellent communication and interpersonal skills.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strong attention to detail and ability to multitask in a dynamic, fast-paced setting.</li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">A collaborative team player that takes initiative.</li> </ul> Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice     ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.            Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.  Key Words: Clinical Trial Manager, Associate Clinical Trial Manager, Clinical Trial Management, Global, Clinical Study Management, Clinical Trials, Phase III Studies, CRO Oversight, Study Start-Up, Vendor Management, TMF, GCP/ICH Compliance, eTMF/CTMS, Clinical Operations, Site Activation, Inspection Readiness, Risk Management, Cross-Functional Collaboration, Protocol Deviations, Enrollment Management, Biotech/Pharma, CNS, Trial Execution. #LI-VH #LI-Hybrid #Clinical Trial Manager # Permanent

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