Clinical Trial Manager

Repertoire Immune Medicines•Cambridge, MA

13h•$112,000 - $160,000•Onsite

About The Position

Repertoire Immune Medicines is a biotechnology company focused on harnessing the human immune system to treat cancer and autoimmune diseases. They utilize the DECODETM platform to characterize T cell receptor (TCR)-antigen pairs and develop novel targeted immune medicines. The company is advancing a pipeline of TCR bispecific molecules for cancer treatment and mRNA tolerizing vaccines for autoimmune diseases. Founded in 2019 by Flagship Pioneering, Repertoire has established collaborations with Genentech and Bristol Myers Squibb. This role involves strategic leadership and hands-on oversight of early-stage oncology trials, including first-in-human trials, ensuring timely, budget-compliant, and regulatory-adherent execution. The Clinical Trial Manager will serve as the main point of contact for various stakeholders, providing guidance, oversight, and risk management in a fast-paced, collaborative environment.

Requirements

Bachelor’s degree in Life Sciences or related field.
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.
Excellent communication skills, with the ability to collaborate effectively across teams.
Highly organized with strong problem-solving, critical thinking, and prioritization skills.

Nice To Haves

Advanced degree preferred.
On-site monitoring experience.

Responsibilities

Manage all aspects of clinical trials with cross-functional teams, ensuring execution on time, on budget, and in compliance with SOPs, ICH/GCP, and regulatory requirements.
Identify and anticipate trial issues or risks impacting budget, resources, and timelines, planning mitigation strategies and escalating as necessary.
Manage outsourced activities with CROs and vendors, including oversight of performance, compliance, development of oversight plans, and review of monitoring reports.
Manage trial budgets and contracts, including forecasting, invoice review, and expense tracking.
Monitor trial progress, including participant enrollment, data review, sample collection, and adherence to timelines, providing regular 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.
Participate in the development and refinement of departmental SOPs, processes, and best practices.