OrciMed Life Sciences is a leading name in the pharmaceutical and clinical research industry, dedicated to advancing healthcare through innovation. With a strong presence in Hyderabad, we specialize in biometrics, clinical data management, and regulatory compliance, offering exciting career opportunities for professionals in the life sciences sector.
Job Title: eTMF Specialist
Location: Hyderabad, India
Work Mode: Work From Office (WFO)
Notice Period: Immediate Joiners Preferred
Experience: 3+ Years in Trial Master File (TMF) Management
Key Responsibilities:
- Manage and maintain the electronic Trial Master File (eTMF) for clinical trials.
- Ensure compliance with ICH-GCP, FDA, and EMA regulations related to TMF documentation.
- Perform quality checks on TMF documents for accuracy and completeness.
- Collaborate with clinical operations, regulatory affairs, and data management teams.
- Support audits and inspections by ensuring all TMF records are inspection-ready.
- Utilize eTMF software (Veeva, SharePoint, or similar) for document management.
Eligibility Criteria:
- Bachelor’s/Master’s degree in Life Sciences, Pharmacy, or related field.
- Minimum 3 years of hands-on experience in TMF management (pharma/CRO industry preferred).
- Strong knowledge of regulatory guidelines (GCP, GMP, 21 CFR Part 11).
- Proficiency in eTMF systems (Veeva, Documentum, etc.).
- Excellent organizational and communication skills.
Employee Benefits:
✅ Competitive salary & performance bonuses
✅ Health insurance & wellness programs
✅ Professional growth in a dynamic work environment
✅ Work-from-office flexibility with a great team
How to Apply?
Send your updated resume to careers@orcimedlifesciences.com with the subject line “Application for eTMF Specialist – Hyderabad”.