September 16 2015 Cortney Greenhalge

The role and skill set of a Clinical Data Manager (CDM) is constantly changing as technology and processes advance. CDMs have evolved into data management leaders, possessing skills in areas such as database building and programming, project management, and budget maintenance, on top of the standard collection, cleaning, and management of subject data in compliance with regulatory standards. With the addition of new regulations and electronic data capture (EDC) systems, more and more data managers are “wearing multiple hats.” The need for well-rounded, informed, and cross-functional CDMs is on the rise. How do we ensure that we, as CDMs, keep pace with the significant technologic advances that have occurred within clinical research over the last 10 to 15 years?

One of the many areas in which key technologic advances have recently enhanced data management is EDC. Electronic data capture is now the preferred choice of sponsors, sites, and clinical professionals.  It is important, and necessary, that CDMs are well versed in all aspects of EDC. The CDM is responsible for designing an EDC system that is programmatically reliable and captures what the sponsor needs for analysis, but is also user friendly at the site level.

The CDM has a unique “triple-bridging” role.  On the first spoke, the CDM works with the sponsor and the sites to design user-friendly forms (screens) and instructions.  On the second spoke, the CDM communicates with the database programmer to build case report form screens and data validation tests and reports.  Thirdly, the CDM must be well-versed in database regulatory requirements and the protocol specifications of the study.  To satisfy all these needs, the CDM must be aware of the level of technical competence of the end-users, which may include study subjects, and understand the capabilities and functions of the EDC system.

Understanding new technologies, being familiar with regulatory requirements and protocol specifications, and understanding sponsor and end-user needs has become the new game-changing role of the CDM; one that offers exciting career advancement for today’s CDM.  Being a well-rounded CDM creates economic efficiencies for sponsors and enhances the CDM’s value in the biopharmaceutical and device industries.

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