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
In recent years, changes in the environment surrounding Clinical Data Managers (CDMs) have been unstoppable; as of 2023, some changes have already been accepted, such as "standardization," "digitization," and "globalization," while others, such as AI, are still developing. 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, Committee on Drug Evaluation
Data Science Subcommittee FY2022 Task Force 1-2
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