What are the responsibilities and job description for the Director, Trial Master File (TMF) Operations position at EPM Scientific?
Job Type: Full-time
Salary: $200K-$215K
Location: San Francisco Bay Area
Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.
The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.
Responsibilities:
- Leading the TMF Operations function to support Clinical Research and Development
- Managing and overseeing the TMF Operations team, including hiring, training, and performance management
- Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
- Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
- Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
- Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
- Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
- Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
An ideal candidate for this role MUST have
- Minimum of 12 years of experience with a Bachelor's degree, or 10 years of experience with a post graduate degree
- Proven leadership experience in an insourced biotech organization
- Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
- Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
Benefits:
- Pre-IPO biotech company
- Competitive salary with comprehensive benefits (100% medical coverage)
- 401K contribution
Salary : $200,000 - $215,000
