Clinical Data Management | Business Analyst
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Working as Clinical Data Manager to Merck (Client) with extensive experience on clinical trials metadata management and clinical data repository or clinical data warehouse is a real time database that consolidates data from a variety of clinical source and clinical applications support, database supporting and development activities. Strong knowledge of Clinical domain and Pharmaceutical Industry. I worked as a Clinical Business Analyst for Imaging and Laboratory clinical data transfer projects.
Seeking an opportunity with a forward-thinking organization, which needs an efficient and energetic employee to make an immediate difference to their business in Clinical trials development/support.
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
