Repertoire Immune Medicines · 7 hours ago
Clinical Trial Manager
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$112K/yr - $160K/yr
3+ years expRepertoire Immune Medicines is a biotechnology company focused on harnessing the human immune system to develop innovative therapies for cancer and autoimmune diseases. The Clinical Trial Manager will provide strategic leadership and oversight for early-stage oncology trials, ensuring they are executed on time and in compliance with regulatory standards.
BiotechnologyLife ScienceMedicalTherapeutics
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
Qualification
Required
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
Ability to travel domestically and internationally, up to 20%
Preferred
advanced degree preferred
On-site monitoring experience (preferred)
Benefits
Medical, dental, vision, and life insurance
Flexible time off
A 401(k) retirement plan
Short- and long-term incentive opportunities
Company
Repertoire Immune Medicines
Repertoire Immune Medicines is a clinical stage biotechnology company.
51-200 employees
H1B Sponsorship
Repertoire Immune Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (4)
2022 (6)
2021 (3)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$257.28MKey Investors
JDRF T1D FundFlagship Pioneering
2021-04-13Series B· $189M
2020-03-25Series Unknown
2019-07-01Series Unknown· $38.28M
Leadership Team
Torben Straight Nissen
Chairman and Chief Executive Officer
Daniel C. Pregibon
Head of Platform Discovery & Technology
Recent News
2025-10-03
DelveInsight Business Research LLP
2025-06-24
Company data provided by crunchbase