Profession

Clinical data manager,as the name implies, is involved in the management of data collected during a clinical trial, that is to say, a medical research project that is conducted to improve the patient health by testing a drug, a method of diagnosis, medical equipment, a protocol of care according to a protocol

The objective of the data manager is to design a database, to ensure reliability of data and to prepare comprehensive file for a statistical analysis in order to answer the question: Does the drug improves health it the patient? The diagnostic method is considered more effective? This new medical equipment is it efficient? This treatment protocol most suitable? ...

During the course of a clinical study, the data manager works in agreement with the sponsor of the study.

Firstly, it performs or assists in the design of a case report that will gather all the necessary medical information for research. The scope of these data is large: demographics, medical history, clinical events, biology, genetics, treatment, quality of life, etc..

Then, the data manager organoversees the data entry in the clinical database dedicated to this study using a CDMS (Clinical Data Management System).

The next step is to check the recorded data. Automatic validation checks are implemented to test the presence and consistency of data, data clarification form are sent to investigators (doctors).

Finally, the data manager performs a review of actions taken to check the database and provides an assessment of the quality of the database before sending data the statistician for analysis.

Throughout its mission, the data manager always follows the rules defined in the study protocol, the CNIL guidelines on the management of personal data, the regulations and other national and international guidelines on medical research projects .

It is likely to work in any academic structure that initiates clinical research: hospital, university, cancer cooperative groups, research association, scholarly society, research organization, health agency ...

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