The key players in Clinical Data Management and their responsibilities

As you may have noticed, the main purpose of these series of posts is to obtain a clear sense of the benefits, demands and challenges involved in carrying out Clinical Data Management (CDM) process. But it is better to focus on one aspect at a time. Today's blog is about the main roles in data management.

 The key players involved in CDM

The CDM team includes specialists who have been recruited to enter, check and analyse the information gathered by the survey team. One of the primary objectives is to keep the number of errors and missing data at a minimum. Therefore, for such an approach to be effective, it is essential to organise the staff members wisely and arrange working processes and workload to ensure everything runs smoothly. 

So, who are the central protagonists in this system? In general, the roster looks like this:

  • Project Supervisor;
  • Project Clinical Data Manager;
  • Data Management Assistant;
  • Database Designer;
  • Database Administrator;
  • Medical Coding Associate;
  • Quality Assurance Associate;
  • Data Entry Manager;
  • Staff responsible for backup and/or storage;
  • Administrative Support.

Obviously, there might be other roles included in the data management process. The internal structure of the Data Management Department in Data MATRIX also has some particularities. For example, in addition to the formal responsibilities, the position of Data Management Assistant includes the vast majority of project responsibilities, namely: data cleaning, term coding, and assistance in maintaining the DM files. Therefore, simply put, this is a right-hand man of a Data Manager. Besides, the assistant is in charge of back-ups.

A few things about the job of a Project Clinical Data Manager: At Data MATRIX it supports the roles of CRF Designer, ECM Developer and Project Manager. That is the way it is organized in our offices. Indeed, we consider that this joint pooling of  activities streamlines the processes, since it is the project manager who is fully immersed in all study details and can take into account all the nuances. 

As for skills and qualification, all members of the Data Management Department should be  methodological and extremely attentive to details,  possess knowledge of technology, organizational and management skills, critical thinking, ability to follow instructions consistently but raise concerns when appropriate, and, of course, have boundless willingness to learn.

20 April 2020

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