What are the responsibilities and job description for the Biotech TMF Operations Leader position at EPM Scientific - Phaidon International?
Job Overview
We are seeking an experienced Clinical Research Manager to lead our Trial Master File (TMF) operations for all clinical trials across the organization.
About the Role
The successful candidate will be responsible for driving change and progress at a strategic level, ensuring TMFs are complete, accurate, and compliant with regulations. This role involves leading the TMF Operations function to support Clinical Research and Development, managing and overseeing the TMF Operations team, and developing and implementing TMF processes and procedures.
Key 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
- Developing and implementing TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
- Collaborating with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
- Managing the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
Requirements
- Minimum of 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
