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