Trial Master File (TMF) Manager

Essential Duties & Responsibilities

• Act as the Clinical Operations Veeva Vault Clinical process owner and TMF subject matter expert, providing guidance and best practices for eTMF, CTMS, Essential Documents, TMF processes, milestone tracking, and BioCryst’s standard TMF Index.
• Lead the development, deployment, maintenance, and continuous improvement of eTMF and CTMS processes, SOPs, Work Instructions, training materials, tools, and filing guidance.
• Setup, organization, maintenance and archival of study-specific eTMF, CTMS records, and SharePoint repositories for Phase I–IV studies ranging from single-site to global multicenter trials.
• Ensure clinical documentation is filed and archived in accordance with applicable SOPs, GCP, ICH guidelines, and retention requirements, and maintain inventory reports and tracking systems so archived paper records can be retrieved promptly from off-site storage.
• Establish study dashboards and organize Veeva Vault Clinical reports that provide study-, country-, and site-level visibility into key metrics, milestones, document completeness, timeliness, quality, and overall TMF health.
• Support integration between Veeva Vault Clinical and other clinical systems, including EDC platforms and CRO partner systems, and collaborate with Veeva Administrators on system configuration, testing, validation, and rollout of new functionality.
• Oversee user access to clinical systems, including account creation, role assignment, periodic access reviews, and timely removal or modification of access as appropriate.
• Maintain and periodically review BioCryst’s standard TMF Index with Clinical Operations staff, functional area representatives, and Veeva Administrators to ensure filing guidance remains current and is implemented consistently across programs.
• Conduct and oversee periodic risk-based reviews of internally managed and CRO-managed TMFs in accordance with SOPs; identify document quality, completeness, and timeliness issues; escalate risks; track deficiencies to resolution; and implement corrective actions or retraining when needed.
• Prepare for, support, and follow up on internal and external audits and regulatory inspections, including document retrieval, issue management, response coordination, and verification that corrective actions are completed.
• Develop and deliver training on TMF processes, the standard TMF Index, filing expectations, system updates, regulatory requirements, and archival requirements; serve as a point of contact for TMF filing and document-management questions.
• Establish and maintain effective communication and collaboration with functional area colleagues -e.g., Clinical Development Sciences, Clinical Development, Regulatory Affairs, Quality Assurance, Data Management, Biometrics, Global Drug Safety and Pharmacovigilance, Clinical Supply Chain, CROs, and other partners to ensure TMFs remain current, complete, high quality, and inspection ready.
• Identify operational needs and implement practical solutions that improve document quality, system use, compliance, efficiency, and departmental effectiveness.
• Perform other duties as assigned.

Experience & Qualifications

• Bachelor’s degree with 7–10 years of relevant clinical research or pharmaceutical industry experience, including a minimum of 5 years of direct TMF/eTMF experience and demonstrated experience leading TMF processes, systems, vendor oversight, and inspection-readiness activities; or an equivalent combination of education and experience.
• Hands-on experience with the DIA TMF Reference Model and the Veeva Vault Clinical application, including the eTMF and aspects of the CTMS.
• Experience with audits, regulatory inspections, CRO oversight, system implementation, training and process improvement.
• Knowledge of Good Clinical Practice (GCP) regulatory requirements and International Conference on Harmonization (ICH) guidelines.
• Ability to identify team needs and suggest/implement solutions for improved departmental functionality.
• Highly motivated self-starter who is capable of taking initiative and seeing projects through to completion with minimal supervision.
• Proficient in computer software systems such as word processing, spreadsheet, and database systems.