TMF Senior Manager, Clinical Operations
The TMF Senior Manager, Clinical Operations serves as the operational leader responsible for the strategy, governance, quality, and execution of the Trial Master File (TMF) across the clinical development portfolio. This role partners cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, Clinical Science, Biometrics, CROs, and study teams to ensure complete, accurate, and inspection-ready TMFs throughout the clinical trial lifecycle.
The ideal candidate is an experienced TMF professional who excels in fast-paced biotech environments, enjoys building scalable processes, and has a strong focus on compliance, quality, and inspection readiness. This position reports to the Head of Clinical Operations.
Key Responsibilities
TMF Strategy & Leadership
- Lead the transition of TMF management from an outsourced model to an in-house capability.
- Implement and optimize the electronic TMF (eTMF) platform and related processes.
- Develop TMF governance, filing standards, SOPs, training materials, workflows, and best practices.
- Identify and implement process improvements, automation, and AI-enabled solutions to enhance TMF quality, efficiency, and inspection readiness.
TMF Management & Oversight
- Serve as the TMF subject matter expert across multiple clinical programs, including early-phase, Phase 2, and Phase 3 studies.
- Partner with study teams to develop TMF plans and ensure timely, accurate, and complete document filing.
- Monitor TMF health through routine reviews and proactively resolve quality and compliance gaps.
- Provide guidance to internal teams, CROs, and vendors regarding TMF standards and expectations.
Inspection Readiness & Compliance
- Partner with Quality Assurance to maintain continuous inspection readiness across all clinical programs.
- Conduct TMF quality assessments and drive resolution of deficiencies and compliance risks.
- Support audits, sponsor inspections, and regulatory inspections through document preparation and retrieval.
- Ensure compliance with ICH-GCP, FDA, EMA, ALCOA+, and applicable regulatory requirements.
Operational Excellence
- Develop dashboards, KPIs, and reporting to monitor TMF completeness, quality, timeliness, and inspection readiness.
- Establish scalable processes and tools that support organizational growth.
- Champion continuous improvement initiatives and adoption of new technologies.
Qualifications
- Bachelor's degree in Life Sciences, Healthcare Administration, or a related field.
- 6+ years of experience in Clinical Operations, Clinical Trial Management, or TMF management within biotech, pharmaceutical, or CRO settings.
- 4+ years of hands-on experience managing eTMFs across global clinical studies.
- Strong knowledge of ICH-GCP, FDA, EMA, ALCOA+, and TMF regulatory requirements.
- Experience leading TMF inspection readiness activities and supporting audits and regulatory inspections.
- Proven ability to develop TMF governance, SOPs, filing standards, and quality management processes.
- Experience with eTMF platforms such as Veeva Vault eTMF, Trial Interactive, or similar systems.
- Strong organizational, communication, and cross-functional collaboration skills.
- Experience with AI-enabled TMF solutions, dashboards, KPIs, and operational metrics is preferred.