TMF Specialist

Role Summary

TMF Specialist

Responsibilities

• Be the primary contact for internal eTMF, CTMS, and any other clinical systems, including implementation, maintenance, and end user training.
• Support activities to ensure the 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 when applicable, uploading, versioning, reviewing, approving, and archiving documents in compliance with applicable regulations and study timelines
• Perform quality control (QC) checks and ensure accuracy, completeness, and compliance of filed documents
• As necessary, assist in the development and maintenance of CTMS, TMF-related standard operating procedures (SOPs), processes, and templates aligned with ICH E6 (R3) and GCP standards
• Conduct routine TMF quality reviews in accordance with the TMF Plan
• Support internal and external inspections and audits related to the eTMF
• Offer technical support and troubleshooting for eTMF and CTMS system users
• Collaborate with cross-functional teams (e.g., Clinical Operations, CROs, Partners etc.) to ensure alignment on eTMF requirements and timelines
• Support Study Operational Leads with the set-up of any TMF with vendors to ensure adequate implementation, including review process, ensuring TMF completeness and managing the transfer of the TMF.
• Performs other related duties and assignments as required

Qualifications

• Bachelor’s degree in life sciences, healthcare, or a related field preferred; equivalent work experience will be considered.
• Minimum of 2+ years of experience working with electronic TMFs, additional experience in clinical research preferred
• 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 in using eTMF systems (e.g., Veeva Vault, Phlexglobal, Wingspan)
• Working knowledge of the DIA reference model
• Hands-on experience with eTMF systems is required.

Education

• Bachelor’s degree in life sciences, healthcare, or a related field preferred; equivalent work experience will be considered.

Additional Requirements

• None