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Clinical Trial Manager
One Kendall Square Cambridge, MA 02139 US
Job Description
Role Overview
We are seeking an experienced Clinical Trial Manager to provide both strategic leadership and hands-on oversight of early-stage oncology trials, including first-in-human trials. Reporting to the Director of Clinical Operations, you will oversee all aspects of trial management -from start-up through close-out - ensuring trials are delivered on time, on budget, and fully compliant with regulatory and quality standards. As the primary point of contact for cross-functional teams, CROs, vendors, and investigative sites, you will provide strategic guidance, operational oversight, and proactive risk management.
This is a hands-on role in a fast-paced, collaborative environment, offering the opportunity to directly influence the advancement of innovative therapies for patients.
Key Responsibilities
- Work with a cross-functional trial teams to manage all aspects of clinical trials ensuring trials are executed on time, on budget, and in compliance with SOPs, ICH/GCP, and regulatory requirements.
- Identify and anticipate trial issues or risks that may impact budget, resources, and timelines; plan mitigation strategies with the cross-functional team and escalates as necessary.
- Manage outsourced activities with CROs and vendors (e.g., biomarker and specialty labs), including oversight of performance, compliance with ICH/GCP and SOPs, development of oversight plans, and review of monitoring reports to maintain trial quality and compliance.
- Manage trial budgets and contracts, including forecasting, invoice review, and expense tracking for accurate reporting.
- Monitor trial progress, including participant enrollment, clinical data review, sample collection, and adherence to timelines; provide regular trial status updates and metrics.
- Guide trial teams and investigator sites to ensure consistent interpretation and execution of trial protocols and procedures.
- Contribute to the development and review of trial-related documents (protocols, ICFs, clinical trial plans, CRFs, manuals, reports, and regulatory documentation).
- Ensure Trial Master File (TMF) completeness, accuracy, and inspection readiness, whether managed internally or outsourced.
- Participate in the development and refinement of departmental SOPs, processes, and best practices.
- Bachelor’s degree in Life Sciences or related field (advanced degree preferred) with 3+ years of clinical trial management experience.
- Proven track record in CRO and vendor management, including oversight of performance, issue resolution, and budget management.
- Ability to lead trials independently, ideally within a small, fast-paced team environment.
- Working knowledge of data management, biostatistics, and pharmacovigilance.
- Global trial experience, including management of multi-country trials from start-up through close-out.
- Thorough understanding of FDA regulations and ICH GCP guidelines.
- Proficiency with clinical trial systems (EDC, CTMS, TMF) and expertise in trial master file organization and regulatory documentation.
- On-site monitoring experience (preferred).
- Excellent communication skills, with the ability to collaborate effectively across teams.
- Highly organized with strong problem-solving, critical thinking, and prioritization skills.
- Ability to travel domestically and internationally, up to 20%.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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