Prasad Vaderahalli Kuberappa Thirtha

Clinical Data Management Manager with 13 years of comprehensive experience in decentralized clinical trials, metadata management, and clinical data repositories (CDR/CDW). Skilled in managing real-time databases that consolidate data from multiple clinical sources and applications, supporting database development and maintenance activities.

Expert in creating and reviewing Clinical Data Management SDLC documents with a focus on scientific accuracy, clarity, regulatory compliance, and consistency across documentation matrices. Proven ability to ensure adherence to GxP and regulatory guidelines while maintaining the highest standards of data quality and integrity.

Responsible for executing end-to-end clinical data management activities, including system development, validation, data collection, integrity review, reconciliation, query management, and database lock preparation (LPLV, IA, DBL). Adept at driving operational excellence and cross-functional collaboration to deliver compliant and submission-ready clinical datasets.

Completed by Bachelor of Engineering in Medical Electronics