TMF Specialist

Role Summary

TMF Specialist who takes pride in precision and understands that rigorous documentation underpins quality clinical science. You will own the organization, quality review, and integrity of essential trial documents within the electronic Trial Master File (eTMF) system. Your work ensures studies stand up to regulatory scrutiny and supports faster delivery of therapies to patients. Location: Remote with occasional travel as needed.

Responsibilities

• Review and quality check trial documents to ensure accuracy and compliance.
• File and maintain essential records in the eTMF system.
• Flag and track quality issues, ensuring they are resolved quickly.
• Support filing and archiving across multiple clinical studies.
• Work closely with TMF Operations Lead to update filing processes and guidelines.
• Help manage periods of high document submission.

Qualifications

• Bachelor’s degree or equivalent
• 2-4 years of experience in clinical trials, TMF, or related roles (Sponsor, CRO, or Site)
• Knowledge of ICH-GCP, good documentation practices, and eTMF systems (e.g., Veeva)
• Organized and detail oriented
• Great communicator and team player

Additional Requirements

• Physical and mental requirements include regular use of a computer and office devices, clear communication, and the ability to focus; accommodations may be provided as needed.