Syneos Health is inviting applications for the position of TMF Specialist I in Hyderabad, India. This is an excellent opportunity for professionals with experience in Trial Master File (TMF), eTMF systems, or Clinical Research Coordination (CRC) to join one of the world’s leading Contract Research Organizations (CROs).
The company is seeking candidates with at least 1 year of experience in TMF Operations, electronic Trial Master File (eTMF), or clinical research documentation. If you have a background in Life Sciences, Pharmacy, or Clinical Research and are looking to grow your career in clinical operations, this role offers excellent learning opportunities and global exposure.
Job Overview
| Details | Information |
|---|---|
| Position | TMF Specialist I |
| Company | Syneos Health |
| Department | Trial Master File (TMF) Operations |
| Job Type | Full-Time |
| Work Mode | Hybrid (Office-based) |
| Location | Hyderabad, Telangana, India |
| Experience | 1+ Years |
| Qualification | B.Sc, M.Sc, B.Pharm, M.Pharm, BDS |
| Industry | Clinical Research / CRO |
| Application Deadline | July 3, 2026 |
Key Responsibilities
As a TMF Specialist I, you will be responsible for maintaining inspection-ready Trial Master Files throughout the clinical trial lifecycle.
Responsibilities include:
- Support Trial Master File (TMF) setup, maintenance, and close-out activities.
- Process clinical study documentation following SOPs, Work Instructions, ICH-GCP, and regulatory guidelines.
- Scan, index, upload, and file documents into electronic Trial Master File (eTMF) systems.
- Maintain secure, accurate, and compliant TMF documentation.
- Conduct Quality Reviews of documents submitted by study teams.
- Perform Completeness Reviews against Expected Document Lists.
- Ensure inspection readiness for regulatory audits.
- Maintain documentation for active and archived clinical studies.
- Collaborate with global clinical operations teams.
Required Qualifications
Applicants should possess:
- Bachelor’s or Master’s degree in Life Sciences or related discipline.
- Eligible Degrees:
- B.Sc
- M.Sc
- B.Pharm
- M.Pharm
- BDS
- Minimum 1 year of experience in:
- Trial Master File (TMF)
- Electronic TMF (eTMF)
- Clinical Research Coordinator (CRC)
- Clinical Research Operations
Preferred Skills:
- Knowledge of ICH-GCP guidelines
- Familiarity with medical terminology
- Experience using eTMF platforms
- Microsoft Office proficiency
- Adobe Acrobat
- Strong documentation skills
- Excellent communication abilities
- Detail-oriented and quality-focused mindset
Why Join Syneos Health?
Syneos Health is among the world’s largest global CROs and supports pharmaceutical, biotechnology, and medical device companies throughout the drug development lifecycle.
Benefits include:
- Global career development opportunities
- Technical and therapeutic area training
- Career progression programs
- Inclusive work culture
- Hybrid work environment
- International clinical research exposure
- Employee recognition and rewards
- Opportunity to work on global clinical trials
Who Should Apply?
This opportunity is ideal for:
- Clinical Research Coordinators (CRC)
- TMF Specialists
- Clinical Trial Documentation professionals
- eTMF Associates
- Clinical Operations Executives
- Life Sciences graduates with TMF experience
How to Apply
