A competent and diligent professional with 17 years of experience in clinical data management, including data entry, database validation, quality control procedures, SOPs, protocol adherence, and compliance with ICH-GCP, NDCT Rules 2019, and 21 CFR Part 11. As the primary point of contact for data management activities, I create and execute project work plans, oversee study start-up, conduct, and close-out, ensure quality and regulatory compliance, and maintain essential documents and the data management trial master file (DMTMF) for assigned projects.
