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.

Aura's 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, @Aura Biosciences, and visit us on Linked In.

Aura Biosciences is the world's 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 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.

• 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…