TMF Specialist I

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 of 1+ years of experience as a Clinical Research Coordinator (CRC) or within a clinical research environment (preferred), with an understanding of clinical trial documentation and applicable regulatory guidelines, or experience with eTMF.
• 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
• Get to know Syneos Health
• Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
• No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
• http://www.syneoshealth.com
• Additional Information

Benefits

Additional Information

TMF Specialist I Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities # TMF Job Summary -TMF - Trial Master File Operations Location - Hyderabad - hybrid Exp Range- 1+ years of experience in E-TMF or Clinical research coordinator 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.

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