Job Description
JD 1: Clinical Study Management Support Specialist
nRole: Clinical Study Management Support Specialist
nResponsibilities:
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- Support global clinical studies across start-up, conduct, and close-out phases.n
- Maintain study trackers, reports, and study documentation.n
- Coordinate with CROs and vendors to ensure study deliverables.n
- Manage TMF and study-related documents.n
- Track study progress, metrics, and compliance issues.n
- Ensure adherence to ICH-GCP, SOPs, and regulatory requirements.n
nMust-Have Skills:
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- Clinical Trial Operationsn
- Study Management Supportn
- TMF Managementn
- CRO/Vendor Coordinationn
- ICH-GCP Knowledgen
- Documentation & Reportingn
- Communication Skillsn