Trial Master File; TMF) Manager

COMPANY:

At Bio Cryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries.

We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at  or follow uson Linked In and Instagram.

The Trial Master File (TMF) Manager is responsible for developing, implementing, and overseeing the processes, systems, training, and operational activities required for the consistent creation, maintenance, quality review, inspection readiness, and archival of Bio Cryst TMFs in accordance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and ICH guidelines. This role serves as a subject matter expert for electronic TMF (eTMF) systems and provides hands‑on leadership for TMF setup, indexing, tracking, filing, periodic review, issue resolution, and archival across Phase I–IV studies ranging from single‑site to global multicenter trials.

The TMF Manager partners with study teams, functional areas, CROs, and system administrators to maintain complete, current, high‑quality TMFs and support regulatory submissions, audits, and inspections.

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 Bio Cryst’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 Bio Cryst’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; elevate 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…