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Kolkata Area, India India

Junior Product Manager at pharmacutical company

Education

• 1. Literature review for information required in the preparation of Clinical Study Protocols/Reports 2. Handling Regulatory submission & queries in respect to Clinical study conduct & Report forms 3. Coordination with the sites and obtaining Ethics Committee approval 4. Periodic monitoring of trial sites for ensuring compliance to the respective protocol and relevant regulatory guidelines. 5. Compilation of all the data generated during the Clinical Trial. 6. Coordination with the site, handling the ethics committee submission and obtaining Ethics Committee approval. 7. Identification of discrepancies / incompliance and generate DCF accordingly and resolution 8. Periodic tracking.