Role: Senior Clinical Data Manager
Location: Chennai, Tamil Nadu
Experience: 10-15 Years
Requirements:
- 10-15 years of experience in clinical trial/data management and data operations.
- Minimum 4-5 years of people management (preferred) experience with proven supervisory
- skills.
- Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
- Strong background in EDC systems management and clinical data operations.
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic
- areas.
Technical Expertise:
- CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
- Deep knowledge of EDC platforms and system integrations.
- Strong understanding of regulatory requirements (HIPAA, FDA, EMA, ICH-GCP).
- Experience with electronic systems validation and 21 CFR Part 11 compliance.
