Senior Clinical Trial Manager, Early-Phase Oncology

Repertoire Immune Medicines; Cambridge (MA); On-site; USD 112,000 - 160,000; Full time

Job summary

Repertoire Immune Medicines in Cambridge, MA seeks a Clinical Trial Manager to lead early‑stage oncology trials, including first‑in‑human studies. You will report to the Director of Clinical Operations and oversee start‑up through close‑out, ensuring trials run on time, on budget, and in compliance with regulatory standards.

This hands‑on role collaborates with CROs, vendors, and investigator sites to drive trial success and risk management in a fast‑paced environment.

Qualifications

• Bachelor’s degree in Life Sciences or related field with 3+ years of clinical trial management experience.
• Proven CRO and vendor management experience, 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.
• Ability to travel domestically and internationally, up to 20%.

Responsibilities

• Work with 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, including oversight of performance and 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, 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.

Skills

CRO management

Vendor management

Trial budgeting

Regulatory knowledge

Cross-functional collaboration

Global trial experience

EDC/CTMS/TMF systems

On-site monitoring

Travel up to 20%

Communication skills

Education

Bachelor’s in Life Sciences

Advanced degree preferred

Tools

EDC

CTMS

TMF

Job description

Repertoire Immune Medicines in Cambridge, MA seeks a Clinical Trial Manager to lead early‑stage oncology trials, including first‑in‑human studies. You will report to the Director of Clinical Operations and oversee start‑up through close‑out, ensuring trials run on time, on budget, and in compliance with regulatory standards.

This hands‑on role collaborates with CROs, vendors, and investigator sites to drive trial success and risk management in a fast‑paced environment.