Catherine Miller is a certified Clinical Data Management professional with over 20 years of experience in the drug development industry. She specializes in clinical trial data review, database design, and comprehensive project oversight from study startup through database lock. Catherine holds a B.S. in Biology and Animal Science from Rutgers University and earned her CCDM® certification from the Society for Clinical Data Management in 2009.
Over the course of her career, Catherine has successfully led numerous clinical trials, serving both as a hands-on Clinical Data Manager and as a strategic departmental leader. Her expertise includes technical project management, study documentation development (DMPs, validation specifications), EDC design and implementation, discrepancy management, safety data reconciliation, and medical coding using MedDRA and WHO Drug dictionaries. She is also highly experienced in applying industry data standards, including CDASH and SDTM.
As a collaborative and detail-oriented leader, Catherine manages Clinical Data Management teams to ensure high-quality deliverables that align with timelines, regulatory requirements, and client expectations. She partners closely with sponsors and cross-functional teams, frequently contributing to business development activities such as bid defenses, investigator meetings, and scientific presentations.
Catherine is currently expanding her expertise in the application of AI tools to improve efficiencies in Clinical Data Management, as well as advancing her knowledge of the General Data Protection Regulation (GDPR). Her focus is on the implications of cross-border clinical research and the operational impact of U.S./EU data sharing and compliance.
Based in Salt Lake City, Utah, Catherine enjoys hiking and skiing in the mountains, often accompanied by her two English Mastiffs.
