National Occupational Standard for Clinical Data Manager

Definition of occupation

The Clinical Data Manager acts as the operational lead for all data management activities for the assigned projects, and ensures they are effectively carried out from project start to closeout. This includes designing case report forms(CRF), and then the collection, storage, integration, review and reconciliation and transfer of clinical trial data. The Clinical Data Manager serves as the primary contact for Data Management on the Core Study Team and the technical leader on all data management aspects for project(s) including start-up, maintenance, close-out activities, and development of Data Management Plans, User Acceptance Testing (UAT) Plans, and Quality Management (QM)plans that will deliver accurate, timely, consistent, and high-quality clinical data. In some cases, they may also oversee the work of vendor organizations involved in clinical trial data management activities.

Clinical Data Managers work closely with the statistics and science teams but are generally not involved in analysis or interpretation of the data collected. They generate and analyze metrics to identify trends in data-related issues. Clinical Data Managers may also be involved in clinical database programming in organizations where this type of training is provided.

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