TMF Specialist 1 (Syneos)

Roles and Responsibilities

Job Responsibilities

Job Summary -TMF – Trial Master File Operations
Location - Madhapur - Office based

Title: TMF Specialist 1
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

Bachelor’s or Master’s degree in Life Sciences or related field:
BSc / MSc / B. Pharm / M. Pharm / BDS

Location - IND- Hyderabad - Hybrid
Minimum of 1+ years of experience as a E-TMF Specialist or 2+ years of exp. as a Clinical Research Coordinator (CRC) or within a clinical research environment (preferred), with an 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