Drug Evaluation Committee
The Ideal Clinical Data Manager and Skill Set for the Future
～Focusing on Vendor Oversight, QMS, and DCT
Data Science Subcommittee
May 2023
The changes in the environment surrounding Clinical Data Managers (CDM) in recent years are endless; as of 2023, some changes have already been accepted, such as "standardization," "digitization," and "globalization," while others are still in the process of development, such as AI. Among these changes, we took up "Vendor Oversight," "Quality Management (QMS)," and "Decentralized Clinical Trial (DCT)," and discussed what the ideal CDMs and their skill sets should be to cope with these changes. We hope that this report will be of help to CDMs working on the front lines and to all stakeholders considering the future image of CDM.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee FY2022 Task Force 1-2