Manager, TMF Management & Oversight
Industry: Clinical Research / Medical Devices / Biotech

We are seeking a Manager, TMF Management & Oversight to serve as a hands‑on Trial Master File (TMF) Subject Matter Expert across our clinical studies. This role is execution‑focused and responsible for ensuring high‑quality, inspection‑ready TMFs in alignment with ICH‑GCP and global regulatory requirements.

This position partners closely with Clinical Operations, study teams, CROs, and vendors, and plays a critical role in driving TMF quality, compliance, and continuous improvement across the study lifecycle.

Key Responsibilities

• Act as a hands‑on TMF SME, managing TMF activities from study start‑up through close‑out
• Own end‑to‑end TMF execution, including setup, maintenance, QC, reconciliation, and close‑out (not just governance)
• Ensure TMF completeness, accuracy, and timeliness in accordance with ICH‑GCP, TMF Reference Model, and internal SOPs
• Lead ongoing TMF QC, quality reviews, reconciliation, and completeness checks across multiple trials
• Drive TMF health metrics, identify gaps, and implement corrective and preventive actions (CAPAs)
• Maintain continuous inspection readiness and actively support audits and regulatory inspections
• Serve as an eTMF system SME (e.g., Veeva Vault TMF), including taxonomy, metadata, configuration support, and user adoption
• Participate in eTMF system enhancements, releases, and UAT activities
• Author and maintain TMF documentation, including TMF Management Plans, content lists, and process documentation
• Manage and oversee CRO and vendor TMF deliverables, ensuring adherence to standards and timelines
• Lead cross‑functional TMF reconciliation with internal teams and external partners
• Support TMF migrations, system implementations, and vendor transitions
• Provide hands‑on training, mentorship, and guidance to study teams and partners
• Contribute to TMF standards, best practices, and continuous process improvement initiatives

Must‑Have Qualifications

• 5-8+ years of direct, hands‑on TMF/eTMF experience in clinical research (execution‑focused)
• Strong expertise in TMF quality management, QC/QR, reconciliation, and inspection readiness
• Deep knowledge of TMF structure, ICH‑GCP, and TMF Reference Model
• Hands‑on experience with eTMF systems (Veeva Vault TMF or equivalent)
• Proven ability to independently identify TMF gaps and drive resolution
• Experience working cross‑functionally with Clinical Operations, study teams, CROs, and vendors
• Strong organizational skills with the ability to manage multiple studies simultaneously
• Excellent communication, problem‑solving, and stakeholder collaboration skills

Preferred Qualifications

• Advanced degree in Life Sciences, Health Sciences, or related field
• Experience supporting regulatory inspections and audits
• Exposure to process improvement initiatives, TMF migrations, or system implementations

Education

• Bachelor's degree in Life Sciences, Health Sciences, or related field required
• Advanced degree preferred