Analysis of Professional Competencies for the Clinical Research Data Management Profession.

Abstract

This job analysis was conducted to compare, assess and refine the competencies of the clinical research data management profession. Two questionnaires were administered in 2015 and 2018 to collect information from data managers on professional competencies, types of data managed, types of studies supported, and necessary foundational knowledge. In 2018 survey, 67 professional competencies were identified. Job tasks differed between early- to mid-career and mid- to late-career practitioners. A large variation in the types of studies conducted and variation in the data managed by the participants was observed. Clinical research data managers managed different types of data with variety of research settings, which indicated a need for training in methods and concepts that could be applied across therapeutic areas and types of data. The competency survey reported here serves as the foundation for the upcoming revision of the Certified Clinical Data Manager (CCDMTM) exam.