COMPANY:
At BioCryst, 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 www.biocryst.com or follow uson LinkedIn and Instagram.
JOB SUMMARY:
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 BioCryst 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.
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.
- Work independently, adapt to changing priorities, exercise sound judgment, and take initiative to complete responsibilities accurately and on time.
- 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.
- Must be a highly motivated self-starter who is capable of taking initiative and sees projects through to completion with minimal supervision.
- Must be proficient in computer software systems such as word processing, spreadsheet, and database systems.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
