Senior TMF Strategy & Compliance Lead

Aura Biosciences; Boston (MA); Hybrid; USD 150,000 - 185,000; Full time

Benefits offered by this job

Health insurance

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive PTO

Disability & life insurance

Job summary

Aura Biosciences is seeking a Senior Manager, Trial Master File to provide strategic oversight, governance, and quality across the clinical trial portfolio. You will ensure TMFs are complete, inspection-ready, and compliant with ICH-GCP, SOPs, and regulatory requirements, whether managed in-house or by CRO partners.

You will lead TMF strategy, governance, and system ownership (Veeva Vault), mentor TMF staff, and collaborate with Clinical Operations, Regulatory Affairs, QA, and external vendors

Qualifications

• Bachelor's degree in life sciences or related field.
• 7+ years clinical research with TMF focus.
• Experience with eTMF systems (Veeva Vault, Montrium, Phlexglobal, Ennov).
• Experience overseeing CRO-managed TMFs and vendor governance preferred.
• Experience supporting regulatory inspections (FDA, EMA, or other health authorities).
• People management or mentorship experience a plus.

Responsibilities

• Develop and maintain TMF governance standards and metadata conventions.
• Provide TMF oversight for assigned studies and ensure timely, complete filing.
• Manage CRO and eTMF vendor relationships and oversight plans.
• Serve as SME for eTMF systems and drive system enhancements.
• Ensure TMFs are audit-ready and support regulatory inspections.
• Collaborate cross-functionally to align document management practices.

Skills

TMF management

ICH-GCP

Regulatory inspections

Vendor governance

Veeva Vault

Cross-functional collaboration

Leadership

Documentation quality

Education

Bachelor's degree in life sciences

Tools

Veeva Vault

Montrium

Phlexglobal

Ennov

Job description

Aura Biosciences is seeking a Senior Manager, Trial Master File to provide strategic oversight, governance, and quality across the clinical trial portfolio. You will ensure TMFs are complete, inspection-ready, and compliant with ICH-GCP, SOPs, and regulatory requirements, whether managed in-house or by CRO partners.

You will lead TMF strategy, governance, and system ownership (Veeva Vault), mentor TMF staff, and collaborate with Clinical Operations, Regulatory Affairs, QA, and external vendors