Location: Gurugram, India (Office-Based)
Company: Syneos Health
Job ID: 25107800
Experience Required: 0–1 year (Freshers eligible with relevant knowledge; 6 months experience preferred)
About the Company
Syneos Health is a globally established biopharmaceutical solutions organization known for accelerating clinical development and commercialization outcomes. With a strong presence across global markets, the organization collaborates with healthcare innovators to deliver high-quality, patient-centric solutions.
Job Overview
The TMF Specialist I role focuses on Trial Master File (TMF) Operations, supporting the setup, maintenance, and close-out of clinical trial documentation. This position is critical in ensuring that TMF records remain accurate, compliant, and inspection-ready throughout the clinical trial lifecycle.
This is an entry-level opportunity suitable for freshers aiming to build a career in Clinical Research, TMF Operations, and Clinical Data Documentation.
Key Responsibilities
Process and manage clinical trial documentation in compliance with SOPs, ICH-GCP guidelines, and regulatory requirements
Support TMF setup, ongoing maintenance, and study close-out activities
Perform document scanning, indexing, filing, and uploading within electronic TMF (eTMF) systems
Ensure accuracy, completeness, and security of TMF documentation across active and archived studies
Conduct quality control reviews of documents submitted by clinical study teams
Perform completeness checks against expected document lists to identify gaps or missing documentation
Collaborate with cross-functional teams to maintain inspection readiness at all times
Eligibility Criteria
Bachelor’s or Master’s degree in Life Sciences or related field (BSc, MSc, B.Pharm, M.Pharm, BDS)
Freshers with strong conceptual understanding of clinical research are encouraged to apply
6 months of experience as a Clinical Research Coordinator (CRC) or similar role is preferred but not mandatory
Basic understanding of clinical trial documentation, TMF structure, and regulatory requirements
Familiarity with medical terminology and clinical research processes
Exposure to eTMF systems will be considered an advantage
Required Skills
Strong attention to detail and quality-focused mindset
Effective written and verbal communication skills
Ability to manage multiple tasks and meet deadlines in a fast-paced environment
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat
Ability to work independently as well as collaboratively within a team
Why This Role is Valuable for Freshers
Direct entry into the clinical research industry through TMF operations
Hands-on exposure to global clinical trial documentation processes
Opportunity to build a strong foundation in ICH-GCP and regulatory compliance
Career pathway toward Clinical Research Associate (CRA), Clinical Trial Assistant (CTA), and Regulatory roles
Important Note for Applicants
Candidates with strong theoretical knowledge of clinical research and documentation standards will have an advantage. This role is ideal for those starting their careers in clinical trials and aiming to grow into advanced roles within the clinical research domain.
How to Apply
Apply through the official careers page of Syneos Health or explore verified global opportunities on ThePharmaDaily.com
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