Position: Director, Trial Master File (TMF) Operations
Our oncology biopharma client seeks a strategic and experienced Director of TMF Operations to lead the TMF function across their clinical trials. This senior-level role will drive process improvements, change management, and ensure the completeness, accuracy, and regulatory compliance of Trial Master Files. The ideal candidate is a strong leader with excellent communication and collaboration skills, capable of managing TMF activities across the clinical trial portfolio. You will be responsible for overseeing the TMF team, vendors, and facilities, as well as developing and implementing TMF processes and ensuring inspection readiness.
About You:
You are a collaborative and results-oriented leader who excels at creating efficient, high-quality processes. You are adept at managing change and utilizing data to drive decisions and improve performance within a clinical research and development environment.
What You'll Do:
- Lead the TMF Operations function in support of clinical research and development.
- Manage and oversee the TMF Operations team, including hiring and development.
- Manage relationships with TMF vendors.
- Oversee TMF facilities and records storage.
- Develop and implement TMF processes, procedures, and training.
- Serve as a subject matter expert for TMF operations and requirements, building strong internal relationships.
- Collaborate with cross-functional teams to ensure TMF completeness and accuracy.
- Manage the quality control of TMF documents in accordance with GCP and regulatory guidelines.
- Develop and establish TMF Key Performance Indicators (KPIs).
- Monitor and report TMF metrics and completeness to management and study teams, identifying and implementing process improvements.
- Serve as the functional TMF lead for regulatory inspections.
- Identify and resolve root causes of performance issues.
- Stay informed of regulatory changes and industry best practices in TMF operations.
- Serve as the eTMF platform business owner, managing system configurations.
- Oversee the sponsor archive.
Qualifications:
- Bachelor's degree with 10+ years in TMF operations within a biotech or pharma sponsored clinical research setting.
- Strong experience with integrating electronic Trial Master File (eTMF) systems and change management processes within Veeva Vault (highly preferred)
- 4+ years of decision-making leadership and team management skills, including cross-collaboration with other teams.
- Strong regulatory requirements understanding (e.g., ICH-GCP, FDA, EMA).
- Must be a strong communicator with the ability to manage multiple projects and deadlines with autonomy
- 3 days onsite minimum