If you’re an experienced Trial Master File professional looking to step into a leadership role, Syneos Health is hiring a TMF Lead I for hybrid work locations across Hyderabad, Pune, Gurugram, and Salem.
This is an excellent opportunity for candidates with expertise in Veeva Vault TMF, inspection readiness, and clinical trial documentation who aspire to grow in a global CRO environment. Syneos Health is known for contributing to 94% of novel FDA approvals over the past 5 years—making this an impactful career move.
🧪 Job Role: Key Responsibilities
As a TMF Lead I, you will:
- Ensure end-to-end TMF inspection readiness across assigned projects.
- Implement and enforce TMF governance and compliance standards.
- Monitor TMF KPIs and initiate corrective/preventive actions.
- Represent TMF Operations during audits and regulatory inspections.
- Lead TMF training, onboarding, and process improvements.
- Collaborate with cross-functional teams, sponsors, and external stakeholders.
- Manage TMF risks, escalations, and documentation timelines.
🎓 Required Qualifications
To be eligible, candidates must have:
✔ Bachelor’s degree in Life Sciences
✔ 5+ years of experience in TMF operations
✔ Minimum 2+ years as TMF Lead or functional lead
✔ Veeva Vault TMF experience (highly preferred)
✔ Experience working in CRO or clinical research environments
Additional skills that strengthen your profile:
- Strong GCP and ICH guideline knowledge
- Excellent documentation, leadership, negotiation, and communication skills
- Understanding of clinical trial operations and regulatory expectations
- Ability to manage multiple projects and timelines
💼 Why Work at Syneos Health?
Syneos Health offers:
- Global project exposure
- Career development, training, and leadership programs
- Supportive culture focused on inclusion and innovation
- Total Rewards & recognition programs
- Hybrid and flexible working models
📍 Work Location
Hybrid – multiple India hubs available:
| Location | Type |
|---|---|
| Hyderabad | Hybrid |
| Pune | Hybrid |
| Gurugram | Hybrid |
| Salem | Hybrid |
📅 Application Deadline
