Harshad Temkar

About Harshad Temkar

Thanks for your valuable time to visit my profile. As an accomplished…

Experience

1. Etmf-specialist-1

   Tata Consultancy Services

   Jun 2024 — Present · Mumbai, IN

   Implement and manage electronic trial master file systems to ensure efficient & compliant document storage & retrieval.• Maintain effective communication channels to update stakeholders on eTMF status, address queries, and ensure transparency in document management processes. • Responsible for pulling different kinds of reports from Veeva Vault for TMF tracking purposes. • Establish and maintain document control processes to organize, categorize, and version clinical trial documents within the eTMF. • Implement measures to maintain the integrity and reliability of data within the eTMF, including routine quality checks and validation processes. • Configuring workflows and permissions to streamline document review and approval processes. • Managed comprehensive Trial Master File (TMF) oversight across multiple clinical trials, ensuring adherence to regulatory standards and facilitating successful inspections. • Worked on TMF health checks to assess document completeness, accuracy, and compliance with FDA and ICH-GCP guidelines, resulting in streamlined document management processes. • Worked on Clinergize tool for collection of site level documents and distribution of study level documents to site by initiating different workflows in tool. • Responsible for pulling different kinds of reports from Veeva Vault for TMF tracking purposes. • Providing assistance for deleting/ obsoleting content issues documents, duplicate documents from Veeva Vault. Handling a delicate task of Delete-Obsolete with admin Access. Providing data to client on routine basis of deleted records.