TMF Specialist I

Title: TMF Specialist 1

Location - Gurugram - Office based

The TMF Operations role is responsible for supporting the set‑up, maintenance, and close‑out of the Trial Master File (TMF) in compliance with client requirements, internal procedures, and global regulatory standards. This role plays a key part in ensuring inspection‑ready TMF documentation throughout the clinical trial lifecycle.

Key Responsibilities

Process study documentation in accordance with SOPs, Work Instructions, ICH‑GCP, regulatory guidelines, and study‑specific requirements

Support TMF set‑up, maintenance, and closure activities across assigned studies

Perform document scanning, indexing, filing, and uploading in electronic TMF (eTMF) systems

Ensure security, accuracy, and compliance of TMF documents for both active and archived studies

Conduct Quality Reviews of TMF documents submitted by study teams

Perform Completeness Reviews against Expected Document Lists to identify missing or incomplete TMF content

Qualification Requirements

Bachelor's or Master's degree in Life Sciences or related field:

BSc / MSc / B.Pharm / M.Pharm / BDS

Minimum 6 months experience as a Clinical Research Coordinator (CRC) or in a clinical research environment (preferred)Understanding of clinical trial documentation and applicable regulatory guidelines

Familiarity with medical terminology and Trial Master File processes

Experience with electronic TMF systems is an advantage

Strong verbal and written communication skills

Excellent attention to detail, organizational skills, and quality mindset

Ability to prioritize multiple tasks and meet deadlines in a dynamic environment

Proficiency in Microsoft Office Suite and Adobe Acrobat

Team‑oriented with the ability to work independently when needed