Career in Clinical Data Management (Part 1) | MMS University

Career in Clinical Data Management (Part 1)

Introduction:

As simple the term may sound, the clinical data management (CDM) is one of the most critical parts of the clinical research lifecycle today. Right from planning the collection of data, ensuring its integrity and putting it in the right format to make it available for analysis, the CDM has grown from an unorganized activity to become the most structured part of clinical research.

The data collected by the CDM team is the basis of driving considerable part of the product development decision in the pharmaceutical industry.

With the advancement of technology, CDM has been standardized over time and it’s interesting to know the various aspects of such an important function of the Clinical Research Organizations.

This article will take you on the journey of CDM professionals and the kind of growth that the industry today offers.

The Job and responsibilities of the CDM Executive includes the following mentioned skills. However, the technical aspects of each of them need to be understood in detail during your training in the company or during preparation for a job.

  1. Designing and reviewing of clinical trial protocols and generate professional input for the clinical trials team
  2. Develop and build database specifications and data validation specification
  3. Create and review clinical trial database design
  4. Validation and analysis plan for the clinical trial, including necessary reports (like CRF) to ensure high-quality and consistent data
  5. Validate and clean data and conduct any kind of medical coding required
  6. Identify errors and inconsistencies, resolve them or find the solution in coordination with the investigational site to ensure high-quality and timely database output
  7. Contribute to preparation of protocols, especially with the data management section
  8. Travel to the site as and when required
  9. Knowledge on EDC or related platforms
  10. Understanding of CDISC compliant SAS® datasets

Takeaway:

For a typical fresher profile, the CDM job industry poses a huge upside with all the major IT companies looking at the candidates with the related understanding and aptitude for CDM.

Clinical data professionals is applicable to a variety of graduate studies right from a master’s degree in life sciences, computer science, or engineering to a graduate certifications in any related areas mentioned.

One of the ways to enter the career is to have a good understanding through one of the clinical data management courses giving you an understanding of the drug research, data management and an emphasis on problem solving ability.

Conclusion:

In overall, the CDM work is integrated with different departments of the Clinical Research organizations and has to work in tandem with the input giver and output receiver.  At the heart of the Clinical data management process, it is inevitable to have a concrete data management plan. Professionals looking to pursue a career in Clinical Research need to have a clear understanding of the drug development process and role and responsibilities of Clinical Data managers in a clinical research environment.

Part 2 Preview:

Career Growth Path of fresher in the Clinical Data Management and the job growth – The next article will highlight the career playbook for the clinical data management aspirants and what the industry holds for you in this competitive job market.

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