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