Associate Director, Trial Master File Operations
Core
Lead Trial Master File (TMF) operations, inspection readiness, and vendor oversight for clinical studies in a biopharmaceutical setting.
Role type
Senior individual contributor (Associate Director) leading TMF operations and governance
Builds
Inspection-ready TMF documentation and operational processes for clinical trials
Domain
Biopharmaceuticals / Clinical Operations
Required skills
TMF operations leadership, inspection readiness, vendor/FSP management, quality control (QC) oversight, metrics management, risk management, GCP knowledge, eTMF system proficiency
Preferred skills
Veeva Vault eTMF experience, CDISC TMF Reference Model familiarity, audit/health authority readiness experience, AI-enabled workflow oversight
Technologies
Veeva Vault eTMF, eTMF systems
Responsibilities
Lead TMF operations to ensure documentation is complete, accurate, timely, and inspection-ready; Manage and oversee FSP TMF resources including workload, performance, and issue resolution; Establish and maintain TMF QC oversight processes including sponsor QC review and sampling; Monitor TMF health metrics to identify trends and risks; Partner with cross-functional teams and vendors to ensure consistent execution of TMF standards
Seniority
Senior, hands-on IC with leadership responsibilities
