Senior Manager, Trial Master File (TMF)

Aura Biosciences•Boston, MA

8d•$150,000 - $185,000•Hybrid

About The Position

Aura Biosciences is looking to expand its Clinical Development Operations (CDO) team with this newly created position of Senior Manager, Trial Master File (TMF). The Senior Manager, Trial Master File (TMF) is responsible for the strategic oversight, governance, and quality of Aura Biosciences Trial Master Files across the company's clinical trial portfolio. This role ensures that TMFs — whether managed in-house or by CRO partners — are complete, inspection-ready, and maintained in compliance with ICH-GCP, applicable regulatory requirements, and internal SOPs throughout the trial lifecycle. The Senior Manager acts as the subject matter expert (SME) for TMF processes, systems, and standards, partnering closely with Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors.

Requirements

Bachelor's degree in life sciences, healthcare, business, or related field required; advanced degree a plus.
7+ years of clinical research experience, with a minimum of 4–5 years focused specifically on Trial Master File management, clinical document/records management, or clinical operations.
Demonstrated experience with eTMF systems (e.g., Veeva Vault, Montrium, Phlexglobal, Ennov) required.
Strong working knowledge of ICH-GCP E6(R2/R3), DIA TMF Reference Model, and applicable global regulatory requirements (FDA, EMA, ICH).
Deep understanding of pharmaceutical and device clinical trial lifecycles and the essential documents required at each stage
Excellent organizational, analytical, and problem-solving skills with strong attention to detail.
Strong written and verbal communication skills; able to present TMF metrics and risks to senior leadership.
Ability to manage multiple studies/priorities simultaneously in a fast-paced environment.
Proficiency with Microsoft Office (Excel, PowerPoint) and clinical systems (CTMS, eTMF, EDC awareness).

Nice To Haves

Prior experience overseeing CRO-managed TMFs and vendor governance strongly preferred.
Experience supporting regulatory inspections (FDA, EMA, or other health authorities) preferred.
Prior people management or mentorship experience a plus.

Responsibilities

Establish and maintain TMF governance standards, including the Reference Model, filing structure, and metadata conventions.
Develop and maintain TMF-related SOPs, work instructions, and plans (e.g., TMF Management Plan) in alignment with ICH-GCP E6(R2/R3) and applicable regulations.
Serve as the primary point of accountability for TMF inspection readiness across all active and archived studies.
Provide TMF oversight for assigned studies, ensuring timely, accurate, and complete filing of essential documents.
Conduct or oversee periodic TMF completeness and quality reviews; track and drive resolution of misfiled, missing, or duplicate documents.
Partner with Clinical Trial Managers/CRAs to ensure real-time filing practices are followed by site- and study-level teams.
Lead TMF reconciliation activities at key milestones (e.g., database lock, study closeout, filing of final study report).
Manage relationships with CRO and eTMF vendor partners; oversee TMF-related deliverables in outsourcing agreements and vendor oversight plans.
Review and approve CRO TMF plans, transfer plans, and TMF health metrics/KPIs.
Lead TMF reconciliation and document transfer activities when transitioning studies between vendors or bringing studies in-house.
Serve as business owner or SME for the eTMF system (Veeva Vault), including configuration, user access, and system enhancements.
Partner with IT/Digital Quality on system validation, upgrades, and integrations (e.g., CTMS-eTMF integration).
Develop and deliver eTMF user training for internal staff and site-facing teams.
Ensure TMFs are audit- and inspection-ready at all times; support regulatory inspections (FDA, EMA, MHRA, etc.) and internal/external audits by preparing TMF documentation and responding to findings.
Monitor and report TMF health metrics (completeness, timeliness, quality) to clinical operations leadership and study teams.
Support CAPA development and implementation for TMF-related audit/inspection findings.
Line-manage and/or mentor TMF Specialists/Coordinators, if applicable, including performance management and development planning.
Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, Data Management, Pharmacovigilance, and Quality Assurance to ensure alignment on document and records management practices.
Represent TMF function in study team meetings, vendor governance meetings, and process improvement initiatives.