Discover our porfessions: Clinical Project Manager
Arnaud Jaruga, Clinical Project Manager presents its profession and the impact of the evolution of regulations on it.
Le métier de Chef de Projet Clinique
Arnaud Jaruga – Clinical Project Manager (Clinical study)
« The Clinical Project Manager is involved very early in the protocol of the study and the drafting of documents related to regulatory submissions. In France it can include independent ethics committee (such as the CPP: Comité de Protection des personnes), the French National Agency for Medicines and Health Products Safety (ANSM) and the National Commission on Informatics and Liberty (CNIL).
The Clinical Project Manager is also in charge of managing and monitoring the progress of the study, managing Clinical Research Associates, contracts, budget monitoring and study stakeholders. All these elements are located upstream of the study.
In the course of the study, it is essential to manage and coordinate the participants, that-is-to-say to answer questions from the centers when the CRA (Clinical Research Associate) is unavailable or cannot answer. It is also necessary to regularly report to sponsors activity reports. At the end of the study, after the statistical analysis, the Clinical Project Manager is responsible for writing the clinical report. In recent times, French regulations have evolved mainly on the deposits to the institutional review board which contributes to the evolution of Soladis’ profession.
In addition, the new General Data Protection Regulation (GDPR) leads Soladis Clinical Studies to review its methodology of drafting consents and patient briefing notes to incorporate new devices. »
Soladis Clinical Studies - France
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59100 Roubaix - FRANCE
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