Drug Evaluation Committee
The Future Role and Skill Set of the Clinical Data Manager
—Focusing on Vendor Oversight, QMS, and DCT—
May 2023
The environment surrounding Clinical Data Managers (CDMs) has been changing at an unprecedented pace in recent years. As of 2023, while some changes—such as “standardization,” “digitization,” and “globalization”—have already been widely accepted, others, such as AI, are still evolving.Against this backdrop, we examined “Vendor Oversight,” “Quality Management Systems (QMS),” and “Decentralized Clinical Trials (DCT)” to explore the ideal role and skill set for CDMs capable of adapting to these changes. We hope this will be of assistance to CDMs working on the front lines, as well as to all stakeholders considering the future of the CDM role.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2022 Task Force 1-2