Clinical Specialist

Tata Consultancy Services · Mumbai, India

JD 1: Clinical Study Management Support Specialist

Role: Clinical Study Management Support Specialist

Responsibilities:

• Support global clinical studies across start-up, conduct, and close-out phases.
• Maintain study trackers, reports, and study documentation.
• Coordinate with CROs and vendors to ensure study deliverables.
• Manage TMF and study-related documents.
• Track study progress, metrics, and compliance issues.
• Ensure adherence to ICH-GCP, SOPs, and regulatory requirements.

Must-Have Skills:

• Clinical Trial Operations
• Study Management Support
• TMF Management
• CRO/Vendor Coordination
• ICH-GCP Knowledge
• Documentation & Reporting
• Communication Skills