What are the responsibilities and job description for the Director, Trial Master File position at EPM Scientific - Phaidon International?
Job Description:
We are seeking a Director, TMF Operations to lead our team in ensuring the accuracy and compliance of Trial Master Files (TMFs) across all clinical trials.
About Us:
A pre-IPO clinical stage biotech is developing therapies for cancer and autoimmune disease. With significant funding from VCs, we continue to advance our clinical programs.
Responsibilities:
- Lead the TMF Operations function in support of Clinical Research and Development
- Maintain strong relationships with TMF third-party vendors, including driving resolution of issues and remediation activities
- Develop and implement TMF processes and procedures, as well as 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
Requirements:
- Minimum 12 years of experience with a Bachelor's degree, or 10 years of experience with a postgraduate 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
