TMF Lead

Position Summary The TMF Lead is an independently resourceful subject matter expert (SME) responsible for the quality, completeness, and inspection readiness of Trial Master Files (TMFs) across assigned clinical studies, from study startup through study closeout and archive, within the Veeva TMF (Vault) system. Operating in a small biotech environment with competing priorities, the TMF Lead works with minimal oversight, serving as the primary go-to resource for all TMF-related questions and driving TMF operational excellence in close collaboration with Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, Quality Assurance, and external CROs/vendors, in adherence to company SOPs, ICH-GCP, and applicable regulatory requirements.

Responsibilities Lead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness at every phase of the trial, within the Veeva TMF (Vault) platform.

Serve as the primary TMF subject matter expert (SME) and go-to resource for study teams, Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, and external CROs/vendors on all TMF-related questions, processes, and requirements.

Develop and maintain TMF management plans, filing strategies, and Expected Document List (EDL) configurations aligned to the DIA TMF Reference Model; review and monitor TMF metrics, KPIs, and quality indicators; perform routine TMF health checks and reconciliation activities.

Conduct TMF Quality Control (QC) reviews and periodic self-inspections; identify TMF risks, gaps, and misfiled or missing documents; drive root-cause analysis and implement corrective and preventive actions (CAPAs).Maintain ongoing inspection readiness for all assigned studies; coordinate document retrieval and responses during sponsor audits and regulatory inspections (FDA, EMA, MHRA, and other health authorities); lead TMF remediation activities and inspection preparation exercises.

Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle.

Configure and administer the Veeva Vault eTMF system for assigned studies, including user access/role management, metadata and document classification, workflow configuration, and support for system upgrades, migrations, or implementation projects.

Partner with Clinical Operations, CRAs, and CRO/vendor TMF counterparts to ensure timely, accurate transfer and filing of site, vendor, and trial-level documents; reconcile CRO-held TMF content against the Expected Document List and the company TMF.Provide TMF training, guidance, and just-in-time coaching to study teams, new hires, and cross-functional stakeholders; facilitate study team meetings focused on TMF compliance and document management.

Track and report TMF workload, completeness, and quality metrics to management; proactively identify and escalate TMF risks and resourcing constraints, particularly given competing study priorities typical of a small biotech.

Contribute to the authorship and continuous improvement of TMF-related SOPs, work instructions, and job aids; drive adoption of TMF best practices across the organization.

Support the identification, assessment, and onboarding of TMF-related vendors/CROs, including participation in TMF-focused RFI/RFP activities and vendor eTMF interoperability assessments.

Independently prioritize and manage TMF deliverables across multiple concurrent studies with minimal supervision, exercising sound judgment in a resource-constrained, fast-paced small-biotech environment.

Additional tasks and projects as requested.

Bachelor's degree in life sciences or a related field; advanced degree a plus.
5-7 years of progressive clinical research experience in the biotechnology/pharmaceutical industry, with a significant focus on TMF operations/management.

Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required).Working knowledge of the DIA TMF Reference Model (TMF RM) and Expected Document List (EDL) management.

Strong knowledge of ICH-GCP, FDA, EMA, MHRA, and other applicable global regulatory requirements governing TMF content and inspection readiness.

Demonstrated experience supporting sponsor audits and/or regulatory inspections,…