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What does a Clinical Data Manager do?

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  • Written By: D. Jeffress
  • Edited By: Bronwyn Harris
  • Last Modified Date: 01 December 2016
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A clinical data manager ensures that statistical information and results from clinical trials are recorded accurately. A professional is usually involved in every aspect of a trial, from selecting qualified participants to publishing final scientific papers. Clinical data managers record information about the effects of medication on patients, daily experimental data, and ongoing issues with a study. Most clinical data manager jobs are found in government organizations, pharmaceutical companies, and biotechnology firms.

Careful data management is essential to guarantee the efficacy of a study. A clinical data manager might participate in a trial for a new medication, behavior therapy technique, or another type of health experiment in which human subjects are used. Before the trial, the data manager must record information about participants. In order for a study to produce meaningful results, subjects must meet several qualifying requirements. The data manager logs information about participants' age, gender, weight, medical history, and other pertinent factors.

Once a trial is underway, the clinical data manager inputs information about the type, dosage, and effects of medications on each group of participants. He or she must be scrupulous in data entry to ensure accuracy. A single figure out of place could significantly skew the results of a study. The data manager works with researchers to make precise statistical calculations and confirm results.

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The clinical data manager delivers results and finished reports from a study to the appropriate authorities for review. If discrepancies or unlikely results are found, the data manager must go back through hundreds of pages of information in an attempt to identify and correct errors. Precise results are necessary for a drug or treatment to be declared acceptable for mass manufacture and distribution.

Most practicing clinical data managers hold bachelor's or master's degrees from accredited universities. A degree in research psychology, medicine, or life science can prepare an individual for the clinical trial atmosphere. In addition, formal experience with information technology and computer systems management is necessary to obtain some jobs. A new clinical data manager usually begins his or her career as an assistant to an established professional, in order to gain experience and learn about the detailed responsibilities of the job.

Some states and countries require clinical data managers to pass certification exams before being authorized to oversee trials. Even in companies and countries that do not require certification, many hopeful data managers pursue voluntary credentials to improve their resumes and their chances of finding good jobs. Most written or computer-based certification examinations test an individual's knowledge of common terminology, techniques, and computer programs. Exams often emphasize the importance of ethics and legal restrictions involved with clinical testing.

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