Associate Director TMF
$165k - $200kGQR
A Clinical-Stage Biotech advancing a cardiometabolic pipeline toward pivotal trials is hiring its Associate Director, Trial Master File. About the Role You will own TMF strategy, governance, and inspection readiness across the portfolio - the sponsor voice for every CRO, and the person leadership trusts when an inspector asks for the file. This is a build, not a cleanup. You set the TMF Reference Model mapping, the KPIs, and the inspection playbook the company carries from Phase I through IV. Responsibilities TMF strategy, governance, and health across Phase I-IV studies Inspection readiness and audit support as the TMF subject matter expert Sponsor oversight of CRO and vendor TMF activities, including the monthly CRO TMF review eTMF completeness, quality, and timely filing - SOPs, CAPAs, risk-based oversight Partnership across Clinical Operations, Quality, Regulatory, and IT Qualifications 8+ years in clinical research (biotech or pharma) with a TMF career built from the ground up Required Skills Deep eTMF expertise - Veeva Vault, Trial Interactive, or Wingspan Command of ICH GCP (E6 R2/R3) and the TMF Reference Model A track record supporting FDA or EMA inspections as the TMF expert Pay range and compensation package Base $165,000-$200,000, plus bonus and equity. Full benefits, 401k match, unlimited PTO. #J-18808-Ljbffr GQR
Vacancy posted 1 day ago
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