Senior Clinical Data Manager

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.