Trial Master File Specialist

TMF Specialist I

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

Job Summary -TMF – Trial Master File Operations
Location - Gurugram - 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

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

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

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Experience Level

Mid Level