Senior Manager, Trial Master File – TMF

Aura Biosciences

Senior Manager governing clinical trial master files for Aura Biosciences, an ocular oncology biotechnology company. Ensuring eTMF quality, compliance, inspection readiness, and vendor oversight.

Posted 8/18/2026full-timeBrighton • Massachusetts • 🇺🇸 United StatesSenior💰 $150,000 - $185,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Trial Master File (TMF) management, ensuring compliance with ICH-GCP and regulatory standards while maintaining inspection readiness. Proficient in managing eTMF systems like Veeva Vault and collaborating across clinical operations to drive document accuracy and completeness.

Highest-signal resume keywords

Trial Master File ManagementETMF Systems ExpertiseICH-GCP KnowledgeClinical Research ExperienceDocument Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Trial Master File ManagementETMF SystemsDocument ManagementRegulatory ComplianceClinical OperationsMicrosoft OfficeData ManagementQuality AssuranceCAPA DevelopmentClinical Document Management

Soft Skills

LeadershipCollaborationMentoringTime ManagementCommunication

Tools & Technologies

Veeva VaultCTMSEDCMontriumPhlexglobalEnnov

Industry Keywords

ICH-GCPDIA TMF Reference ModelClinical TrialsPharmaceuticalDevice Clinical Trials

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

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 in alignment with ICH-GCP and applicable regulations
Serve as the primary point of accountability for TMF inspection readiness across active and archived studies
Provide TMF oversight for assigned studies, ensuring timely, accurate, and complete filing of essential documents
Conduct or oversee TMF completeness and quality reviews and drive resolution of misfiled, missing, or duplicate documents
Partner with Clinical Trial Managers and CRAs to ensure real-time filing practices
Lead TMF reconciliation activities at key milestones
Manage CRO and eTMF vendor relationships and oversee TMF-related deliverables
Review and approve CRO TMF plans, transfer plans, and TMF health metrics/KPIs
Lead TMF reconciliation and document transfer activities during vendor transitions or insourcing
Serve as business owner or SME for the Veeva Vault eTMF system, including configuration, user access, and enhancements
Partner with IT/Digital Quality on system validation, upgrades, and CTMS-eTMF integrations
Develop and deliver eTMF user training
Ensure TMFs remain audit- and inspection-ready and support regulatory inspections and audits
Monitor and report TMF health metrics to clinical operations leadership and study teams
Support CAPA development and implementation for TMF-related findings
Line-manage and/or mentor TMF Specialists/Coordinators, if applicable
Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, Pharmacovigilance, and Quality Assurance
Represent the TMF function in study team meetings, vendor governance meetings, and process improvement initiatives

Requirements

What you’ll need

Bachelor's degree in life sciences, healthcare, business, or related field required
7+ years of clinical research experience
Minimum of 4–5 years focused on Trial Master File management, clinical document/records management, or clinical operations
Demonstrated experience with eTMF systems such as Veeva Vault, Montrium, Phlexglobal, or Ennov
Strong working knowledge of ICH-GCP E6(R2/R3), DIA TMF Reference Model, and applicable global regulatory requirements
Deep understanding of pharmaceutical and device clinical trial lifecycles and essential documents required at each stage
Proficiency with Microsoft Office, including Excel and PowerPoint
Awareness of clinical systems including CTMS, eTMF, and EDC
Ability to manage multiple studies and priorities simultaneously in a fast-paced environment
Occasional travel of approximately 20%

Benefits

Comp & perks

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