Job Description
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
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