Senior Manager, Trial Master File (TMF

Senior Manager, Trial Master File (TMF)

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.

• TMF Strategy & Governance
• Study-Level Oversight
• Vendor & CRO Management
• Systems & Technology
• Inspection Readiness & Quality
• Leadership & Collaboration

• Education
• Experience
• Knowledge & Skills

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

Salary Range: $150,000/yr - $185,000/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