Manager, TMF Operations
Exciting Opportunity: Manager, TMF Operations
We're partnering with an innovative clinical-stage biopharmaceutical company to find a skilled Manager, Trial Master File (TMF) Operations. This is a fantastic opportunity to join a fast-paced environment at the forefront of transformative drug development. In this highly visible role, you'll play a key part in driving TMF strategy and ensuring inspection readiness across multiple global studies.
The role would be based out of the Millbrae, CA, Jersey City, NJ, or New York, NY offices and will require 3 days a week on site.
What you'll do:
Oversee the maintenance and quality of the Trial Master File (TMF) for ongoing clinical trials
Collaborate cross-functionally with Clinical Operations, QA, and external partners to ensure timely document collection, filing, and compliance
Perform TMF QC checks and support inspection readiness efforts
Serve as the subject matter expert for eTMF systems (e.g., Veeva) and TMF reference models
Support development and refinement of SOPs and TMF processes
What we're looking for:
4-6+ years of experience in TMF operations or clinical documentation in a biotech, pharma, or CRO environment
Strong knowledge of GCP, TMF Reference Model, ALCOA+ principles, and good documentation practices (GDP)
Hands-on experience with eTMF platforms, preferably Veeva
Excellent attention to detail and communication skills
Ability to work independently and manage competing priorities in a growing organization
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