Senior Manager, Trial Master File (TMF)
Aura Biosciences
August 18, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Responsibilities
- Establish and maintain TMF governance standards (Reference Model, filing structure, metadata conventions).
- Develop/maintain TMF SOPs, work instructions, and plans (e.g., TMF Management Plan) aligned with ICH-GCP and regulations; ensure TMFs are complete and inspection-ready.
- Provide TMF oversight for assigned studies: ensure timely, accurate, complete filing; run/oversee periodic TMF completeness/quality reviews; resolve misfiled/missing/duplicate documents.
- Partner with Clinical Trial Managers/CRAs to ensure real-time filing; lead TMF reconciliation at key milestones (database lock, closeout, final report filing).
- Manage CRO/eTMF vendor relationships: oversee TMF deliverables, review/approve CRO TMF/transfer plans and TMF health metrics/KPIs; handle reconciliation/document transfer when transitioning vendors or bringing studies in-house.
- Serve as SME/business owner for eTMF system (Veeva Vault): configuration, user access, enhancements; support validation/upgrades/integrations; deliver eTMF user training.
- Support audits/inspections and CAPA for TMF-related findings; monitor/report TMF health metrics.
- Line-manage/mentor TMF Specialists/Coordinators (if applicable) and collaborate cross-functionally.
Qualifications
- Bachelor’s degree (life sciences/healthcare/business or related) required; advanced degree a plus.
- 7+ years clinical research experience, including 4–5 years focused on Trial Master File management/clinical records or clinical operations.
- Demonstrated eTMF experience (e.g., Veeva Vault, Montrium, Phlexglobal, Ennov) required.
- CRO-managed TMF and vendor governance experience strongly preferred; regulatory inspection support preferred; people management/mentorship a plus.
Skills
- Strong ICH-GCP E6(R2/R3) and DIA TMF Reference Model knowledge; understanding of clinical trial essential documents.
- Excellent organization, analysis, problem-solving, and attention to detail; strong written/verbal communication.
- Ability to manage multiple studies; proficiency with Microsoft Office (Excel, PowerPoint) and clinical systems (CTMS, eTMF; EDC awareness).
Benefits
- Health insurance with FULL premium coverage; 401K with company match; ESPP; competitive PTO; company-paid short & long-term disability and life insurance.
Working Conditions
- Remote/hybrid or onsite; occasional travel (~20%).
- Establish and maintain TMF governance standards (Reference Model, filing structure, metadata conventions).
- Develop/maintain TMF SOPs, work instructions, and plans (e.g., TMF Management Plan) aligned with ICH-GCP and regulations; ensure TMFs are complete and inspection-ready.
- Provide TMF oversight for assigned studies: ensure timely, accurate, complete filing; run/oversee periodic TMF completeness/quality reviews; resolve misfiled/missing/duplicate documents.
- Partner with Clinical Trial Managers/CRAs to ensure real-time filing; lead TMF reconciliation at key milestones (database lock, closeout, final report filing).
- Manage CRO/eTMF vendor relationships: oversee TMF deliverables, review/approve CRO TMF/transfer plans and TMF health metrics/KPIs; handle reconciliation/document transfer when transitioning vendors or bringing studies in-house.
- Serve as SME/business owner for eTMF system (Veeva Vault): configuration, user access, enhancements; support validation/upgrades/integrations; deliver eTMF user training.
- Support audits/inspections and CAPA for TMF-related findings; monitor/report TMF health metrics.
- Line-manage/mentor TMF Specialists/Coordinators (if applicable) and collaborate cross-functionally.
Qualifications
- Bachelor’s degree (life sciences/healthcare/business or related) required; advanced degree a plus.
- 7+ years clinical research experience, including 4–5 years focused on Trial Master File management/clinical records or clinical operations.
- Demonstrated eTMF experience (e.g., Veeva Vault, Montrium, Phlexglobal, Ennov) required.
- CRO-managed TMF and vendor governance experience strongly preferred; regulatory inspection support preferred; people management/mentorship a plus.
Skills
- Strong ICH-GCP E6(R2/R3) and DIA TMF Reference Model knowledge; understanding of clinical trial essential documents.
- Excellent organization, analysis, problem-solving, and attention to detail; strong written/verbal communication.
- Ability to manage multiple studies; proficiency with Microsoft Office (Excel, PowerPoint) and clinical systems (CTMS, eTMF; EDC awareness).
Benefits
- Health insurance with FULL premium coverage; 401K with company match; ESPP; competitive PTO; company-paid short & long-term disability and life insurance.
Working Conditions
- Remote/hybrid or onsite; occasional travel (~20%).