Trial Master File Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Serve as the Clinical Operations Veeva Vault Clinical process owner and expert on TMF.

• Lead the creation, implementation, upkeep, and continuous enhancement of eTMF and CTMS processes, standard operating procedures (SOPs), work instructions, training materials, tools, and filing guidelines.

• Establish, organize, maintain, and archive study-specific eTMF, CTMS records, and SharePoint repositories for Phase I–IV studies.

• Ensure that clinical documentation is filed and archived in accordance with SOPs, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and retention requirements.

• Manage inventory reports and tracking systems for archived paper records.

• Create study dashboards and arrange Veeva Vault Clinical reports for study-, country-, and site-level metrics and TMF health.

• Facilitate integration between Veeva Vault Clinical and other clinical systems, including Electronic Data Capture (EDC) platforms and CRO partner systems.

• Collaborate with Veeva Administrators on system configuration, testing, validation, and deployment of new features.

• Supervise clinical-system user access, role assignments, access reviews, and access modifications.

• Maintain and periodically review BioCryst’s standard TMF Index.

• Conduct and supervise risk-based reviews of both internally managed and CRO-managed TMFs; identify issues, escalate risks, track deficiencies, and implement corrective actions or retraining.

• Prepare for and assist in internal/external audits and regulatory inspections, including document retrieval, issue management, response coordination, and verification of corrective actions.

• Develop and provide training on TMF processes, filing expectations, system updates, and regulatory and archival requirements.

• Act as the primary contact for TMF filing and document management inquiries.

• Collaborate with clinical, regulatory, quality, data, safety, supply chain, CRO, and other partners to ensure TMFs are current, complete, high-quality, and ready for inspection.

• Identify operational needs and implement solutions to enhance document quality, compliance, efficiency, and departmental effectiveness.

• Work autonomously, adapt to shifting priorities, exercise sound judgment, and take initiative.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree with 7–10 years of relevant experience in clinical research or the pharmaceutical industry, including at least 5 years of hands-on TMF/eTMF experience and proven leadership in TMF processes, systems, vendor oversight, and inspection readiness activities; or an equivalent combination of education and experience.

• Practical experience with the DIA TMF Reference Model and the Veeva Vault Clinical application, encompassing eTMF and components of the CTMS.

• Familiarity with audits, regulatory inspections, CRO oversight, system implementations, training, and process improvements.

• Understanding of Good Clinical Practice (GCP) regulatory requirements and International Conference on Harmonization (ICH) guidelines.

• Capability to identify team needs and propose/execute solutions for enhanced departmental functionality.

• Must be a self-motivated individual who can take initiative and see projects through to completion with minimal supervision.

• Proficiency in computer software systems such as word processing, spreadsheets, and database management systems.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and advancement within the organization.

• Supportive and collaborative work environment fostering innovation and growth.