Senior Manager, Trial Master File (TMF)

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing bel-sar a potentially transformative first-in-class therapy for patients living with ocular cancers. Bel-sar represents an entirely novel approach to treating ocular cancers via its dual mechanisms of action of acute tumor necrosis and secondary anti-tumor immune activation. The Phase 3 registration study of Bel-sar in early choroidal melanoma the largest patient segment of uveal melanoma is fully enrolled and earlier stage studies in metastases to the choroid and cancers of the ocular surface are ongoing. Auras mission is to improve outcomes for patients living with ocular cancers by delivering a therapy that not only arrests tumor growth but also preserves vision and quality of life.

For more information visit. Follow us on X @AuraBiosciences and visit us on LinkedIn.

Position Summary

Aura Biosciences is the worlds preeminent ocular oncology company. We are leveraging a novel targeted oncology platform to develop a potential new standard of care with a focus on ocular oncology.

We are looking to expand our Clinical Development Operations (CDO) team with this newly created position ofSenior 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 companys 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.

Key Responsibilities

TMF Strategy & Governance

• 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.

Study-Level Oversight

• 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).

Vendor & CRO Management

• 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.

Systems & Technology

• 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.

Inspection Readiness & Quality

• 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.

Leadership & Collaboration

• 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.

Qualifications

Education

• Bachelors degree in life sciences healthcare business or related field required; advanced degree a plus.

Experience

• 7 years of clinical research experience with a minimum of 45 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.
• 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.

Knowledge & Skills

• 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).

Working Conditions

• Remote/hybrid or onsite
• Occasional travel (20%) for CRO/vendor meetings audits or inspections.

Salary & Benefit Information

Salary Range: $150000/yr - $185000/yr

(Placement within the listed range depends on many factors including but not limited to: geographic location degree years of experience and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance

Required Experience:

Senior Manager