Trial Master File (TMF) Associate

Role: Trial Master File (TMF) Associate supporting clinical trial documentation management within biopharma. Primary objectives include ensuring TMF accuracy, completeness, and inspection readiness throughout trial lifecycle. Responsibilities encompass maintaining TMF records, conducting quality control reviews, monitoring metrics, supporting vendor and CRO reconciliation, and preparing for audits and inspections. Requirements: Bachelor's in Life Sciences or related field; 2-4+ years experience in TMF, clinical operations, or research within biotech, pharma, or CROs; strong knowledge of ICH-GCP R(3), 21 CFR Part 11, CDISC TMF standards; hands-on experience with Veeva Vault eTMF or Trial Interactive platforms; proven ability to support quality and compliance initiatives. Preferred qualifications include experience with FDA BIMO inspections, supporting global studies, and process improvement activities. The role emphasizes collaborative engagement with clinical teams, CROs, vendors, and regulatory bodies, with a focus on maintaining an audit-ready TMF environment. Work setup can be remote or hybrid (Waltham, MA or Menlo Park, CA), with no travel specified.