Trial Master File (TMF) Associate

Role: Trial Master File (TMF) Associate supporting clinical trial documentation management for biopharma development. Responsibilities: maintain and ensure completeness, accuracy, and regulatory compliance of TMF records; perform quality control reviews; monitor TMF health metrics; collaborate with Clinical Operations, CROs, vendors, and study teams; support audits, inspections, reconciliation activities, and process improvements; assist with TMF system adoption and documentation. Requirements: Bachelor's in Life/Health Sciences; 2-4+ years in TMF management, clinical operations, or research within biotech/pharma/CRO settings; experience with eTMF platforms (Veeva Vault, Trial Interactive); knowledge of ICH-GCP, 21 CFR Part 11, and FDA/global regulatory standards; proficiency in TMF quality control, reconciliation, and inspection readiness. Preferred: experience supporting FDA BIMO inspections, global studies, CTMS platforms, SOP development, and process improvements. HighValue: TMF management, eTMF systems, regulatory compliance, inspection support, clinical research operations, biotech/pharma environment, remote/hybrid in Waltham, MA or Menlo Park, CA. Work setup: remote or hybrid 3 days/week.