TMF Specialist
Nuvation Bio
Full-time
Remote friendly (United States)
United States
Operations
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Role Summary
TMF Specialist responsible for collecting, reviewing, maintaining, and archiving essential regulatory documents for the Trial Master File (TMF) in accordance with GCP, ICH E6, and applicable regulations and SOPs. Collaborates with Clinical Operations, Clinical Quality, and other teams to ensure the TMF is current and inspection-ready, with potential duties as System Owner for Clinical Operations systems.
Responsibilities
- Be the primary contact for internal eTMF, CTMS, and other clinical systems, including implementation, maintenance, and end user training.
- Ensure clinical systems used by Clinical Operations are validated and compliant with regulatory guidelines (e.g., ICH GCP, FDA, EMA).
- Manage the eTMF document lifecycle, including uploading, versioning, reviewing, approving, and archiving documents in line with regulations and study timelines.
- Perform quality control checks to ensure accuracy, completeness, and compliance of filed documents.
- Assist in the development and maintenance of CTMS, TMF-related SOPs, processes, and templates aligned with ICH E6 (R3) and GCP.
- Conduct routine TMF quality reviews per the TMF Plan.
- Support internal and external inspections and audits related to the eTMF.
- Provide technical support and troubleshooting for eTMF and CTMS system users.
- Collaborate with cross-functional teams to align on eTMF requirements and timelines.
- Support Study Operational Leads with TMF setup with vendors, including review processes, TMF completeness, and transfer management.
- Performs other related duties as required.
Qualifications
- Required: Bachelor’s degree in life sciences, healthcare, or related field (preferred); equivalent work experience considered.
- Experience: Minimum of 2+ years working with electronic TMFs; familiarity with clinical trial operations and ICH/GCP guidelines.
Skills
- Excellent organizational, communication, and problem-solving skills
- Ability to work independently and collaboratively in a fast-paced environment
- Proficiency with eTMF systems (e.g., Veeva Vault, Phlexglobal, Wingspan)
- Working knowledge of the DIA reference model
- Hands-on experience with eTMF systems is required
- Excellent written and verbal communication in English; Chinese is a plus
Education
- Bachelor’s degree in life sciences, healthcare, or related field preferred; equivalent work experience will be considered.
Additional Requirements
- Note: Travel not specified; no additional physical requirements listed.