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The medical element of several international studies, frequently spanning the whole of Europe, furthermore the Europe elements of global studies spanning several continents, are directed from Hungary.
The scope of medical advisors is extremely varied, running from the initiation of a study to its conclusion. Primary elements: formulating the medical aspects of plans drafted at the request of clients, participation at competition negotiations, active cooperation in the preparation of commissioned studies. At the beginning of studies a critical element of the process is the sharing of viewpoints related to the involvement strategy and avoidance of medical-related problematics, pitfalls of the studies with the group heading the study. When launching the study the medical advisor briefs the investigators and monitors on the protocol-related medical elements, then during the study the advisor is charged with responding to questions raised by investigators and CRAs. Once the first patient is involved the medical advisor tracks compliance with conditions on patient involvement, the safety of subjects involved in the study, and analysis the resulting data with particular regard to undesirable events (side effects), laboratory and ECG results. At the end of the study the medical advisor has a role in control and analysis of data, evaluation of the final results as well as reviewing, from a medical aspect, the clinical study report.
The Medical Surveillance group, which tracks every single laboratory and ECG result, is unique among CROs and sponsors.
I work at Quintiles as a medical advisor. My sphere of responsibilities is broad, extending to every stage of clinical studies and combining both medical and clinical study work. The job itself is extremely varied and demands a diverse range of skills since besides having an overview of the latest results and medical literature in the given area one must be able to recognize their practical consequences, too. I have to negotiate with the client, work closely with the group leading the study, hold courses for the CRAs and brief the investigators on the study plan.
In this area, as in virtually all areas of clinical studies, Quintiles is the leader. Very few contracted clinical research organizations (CRO) have a medical section and not one employs as many doctors.
I thoroughly enjoy working at Quintiles, which is able to provide excellent working conditions; I enjoy the international work and the company’s dynamism and innovative spirit.