Clinical Data Management

Thursday, April 07, 2005

Why are there not enough Clinical Research Data Management Specialists on the market?

Kriger CDM Training: Data Management Program , ,

This article has been published by the International Biopharmaceutical Association

The project is sponsored by KRC CRO and training services ( ) and ClinQua CRO ( )

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Why are there not enough Clinical Research Data Management Specialists on the market and why is it important to train the new specialists out of other professions with the right educational background?
In fact, the market is currently expanding faster than the production of new qualified professionals which inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to overcome, but the truth is that everybody working in this industry had to start somewhere and as the industry grows positions need to be filled. Now the question is: how will this be accomplished? One way of filling the vacuum is to take specialists from other professions and turn them into professionals for this industry. This has several added benefits of its own. For instance bringing specialists from other professions or industries actually diversifies the workforce and brings new perspectives to the biopharmaceutical industry. This in turn is a source of innovation where multiple disciplines are being united and new perspectives are made more apparent.
Of course, the need for training is obvious for specialists that are re-aligning their careers as well as for individuals that are entering the industry as new graduates. Most of the skills and knowledge required in positions such as CRA’s, CDM’s, QA’s and Marketing Managers are not covered in university courses. Even where an individual has been through a specially designed training program for the position through an academic institution, the training may not involve a practical component in which case the individual still lacks certain skills. This should re-emphasize the importance of practical training programs for the biopharmaceutical industry.
The educational system does not appear to produce enough graduates to meet the demand for entry level positions like CRA, Data Manager Specialists, Quality Assurance Specialists and Marketing and Management specialists. Skill shortages also affect the ability of regulatory agencies to keep abreast of scientific advances and to efficiently review the increasing number of new products. The diverse range of skills required along with the dramatic pace of change is not reflected in current university courses. The shortage of specialists could be felt in other areas too. For example, bioinformatics requires a background in genetics, statistics, and software development, but most graduates lack such multi-disciplinary training. Also, there are no undergraduate degree programs in bioengineering; specialization options are normally offered within more traditional programs.