Syneos Health, a globally recognized biopharmaceutical solutions organization, is actively building its talent pipeline for Clinical Operations Specialist (ClinOps) / Sr COS in Pune and TMF Specialist I in Gurugram. These roles present excellent opportunities for candidates in clinical research, TMF operations, and clinical trial documentation.
With operations spanning over 110 countries, Syneos Health plays a critical role in accelerating drug development and delivering innovative therapies. Candidates with experience in ICH-GCP, Trial Master File (TMF), and clinical trial processes are strongly encouraged to apply.
Job Overview
- Company: Syneos Health
- Job Roles: Clinical Operations Specialist / Sr COS, TMF Specialist I
- Locations: Pune (ClinOps), Gurugram (TMF)
- Job Type: Full-Time, Office-Based
- Experience: 0.5 โ 3 Years
- Industry: Clinical Research / CRO
- Employment Mode: Office-based
Key Responsibilities
Clinical Operations Specialist (Pune)
- Support clinical monitoring and site management activities
- Ensure compliance with ICH-GCP guidelines and study protocols
- Maintain and manage Trial Master File (TMF) documentation
- Track clinical trial data and regulatory documents
- Coordinate site communication and manage study-related queries
- Assist in audit readiness and document quality checks
- Organize study meetings and prepare reports
TMF Specialist I (Gurugram)
- Perform TMF set-up, maintenance, and close-out activities
- Manage electronic TMF (eTMF) systems (uploading, indexing, filing)
- Conduct quality review and completeness checks of TMF documents
- Ensure compliance with regulatory standards and SOPs
- Support audit readiness and inspection preparation
- Maintain document accuracy and security
Qualifications & Eligibility
- Education: BSc / MSc / B.Pharm / M.Pharm / Life Sciences degree
- Experience:
- ClinOps: 1โ3 years CTA/clinical trial experience
- TMF Specialist: Minimum 6 months CRC/clinical research experience
- Strong understanding of:
- ICH-GCP guidelines
- Clinical trial documentation
- Trial Master File (TMF) processes
- Proficiency in Microsoft Office and eTMF systems (preferred)
- Excellent communication and organizational skills
Skills Required
- Clinical research coordination
- TMF documentation and compliance
- Attention to detail and quality mindset
- Multitasking and deadline management
- Strong interpersonal communication
Salary & Benefits
- Estimated Salary Range: โน3.0 โ โน6.5 LPA (based on experience)
- Career development and training programs
- Exposure to global clinical trials
- Inclusive and collaborative work culture
- Opportunities for internal growth and promotion
Why Join Syneos Health?
Syneos Health has contributed to 94% of FDA-approved drugs in recent years, making it a leader in clinical research and development. Employees benefit from:
- Global exposure in clinical operations
- Structured learning and development programs
- Strong emphasis on work-life balance and inclusion
- Opportunity to work on high-impact clinical trials
How to Apply
Application Link For Clinical Operations Specialist / Sr COS
Application Link For TMF Specialist I
