Trial Master File Specialist

A company is looking for a TMF Specialist to manage the Trial Master File and ensure compliance with regulatory guidelines.

Key Responsibilities

Serve as the primary contact for internal eTMF, CTMS, and clinical systems, including implementation and user training

Manage the eTMF document lifecycle, ensuring compliance with regulations and study timelines

Conduct routine TMF quality reviews and support internal and external inspections related to the eTMF

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 with electronic TMFs; clinical research experience preferred

Familiarity with clinical trial operations and ICH / GCP guidelines

Proficiency in using eTMF systems (e.g., Veeva Vault, Phlexglobal, Wingspan)

Hands-on experience with eTMF systems is required