Clinical Trial Administrator
NOVO NORDISK INDIA Private LTD. Bangalore
08.2023 - Current
- Managed sponsor Trial Master File (TMF) activities, including document review, quality control, and upload into the VEEVA Clinical Trial Management System
- Customized, translated, and verified country/site-specific Participant Information Sheets and Informed Consent Forms
- Preparation of Contracts and agreements, obtaining necessary signatures and upload to COUPA.
- Responsible for updating national clinical trial registers (e.g. CTRI) with new or updated study related information.
- Prepared Site Initiation Visit (SIV) kits and ensured on-site presence during SIVs to support site readiness and compliance.
- Preparation of clinical trial application dossier and dispatch for EC submissions
- Tracking study specific events and/or documents, and maintenance appropriate logs
- Coordination with CRAs to ensure CIOMS/SAE tracking tools are up to date for timely and accurate safety reporting to PIs, ECs
- Processing invoice and tracking trial related payments (e.g. investigator fees and EC fees)
- Attended a training visit to an investigator site to strengthen operational understanding of clinical trial processes.
- Reviewed the Investigator Trial Master File (ITMF) to ensure compliance with documentation standards and regulatory requirements.
- Assessed subject files for completeness, accuracy, and alignment with Good Clinical Practice (GCP) guidelines.
- Evaluated Drug Accountability (DUN) records to verify proper tracking, storage, and reconciliation of investigational products
Additional responsibilities:
- Global Directory Administrators: As gatekeeper of global directory records, to create and maintain organization s and locations, review selected persons record to avoid duplicate.
- HCO clean-up initiative in India: It was focused on resolving duplicate and outdated organization records in CTMS (Clinical trial management system) ensuring accurate site and department details for clinical trials.