Gavisiddeshwara E

Trial Execution & Support: Support Clinical Trial Managers and CRAs in the start-up and maintenance of clinical studies, ensuring 100% inspection readiness of TMF/ISF. Regulatory Submissions: Manage IRB/Ethics Committee submissions and maintain trackers for safety reports, IBs, and regulatory approvals. Document Management: Coordinate study document translations and ensure high-quality filing of electronic and physical trial records. Administrative Oversight: Manage site set-up activities, including the preparation of Pharmacy Files and Investigator Site Files prior to SIVs. Logistics & Finance: Track trial product supplies, manage site logs, and oversee sponsor payment milestones.