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Nicolas FORTIN

MARCY-L'ETOILE

En résumé

Mes compétences :
Management
Project
Essais cliniques
Pharmacien
In Vitro Diagnostic

Entreprises

  • BioMérieux - Head of clinical project management group

    MARCY-L'ETOILE 2010 - maintenant Head of a 12 clinical scientists department, in charge of :

    > Managing international clinical trial projects for the purpose of CE marking, US-FDA and ROW registrations, from trial design to closure, with respect to usual projects-related keystones : quality standards, regulatory strategies, budget and time to market.

    > Managing the project for the implementation of the clinical evidence requirements as per the new IVD-MD CE regulation

    > Supporting local Chinese clinical trial teams in the context of China-FDA registrations: advises on design issues, tools and processes implementation.

    > Developing functional excellence through active and regular watch and update of training policies and modules related to the clinical trial activities: project management, design control, clinical trial process, trial design issues, Good Clinical Practices.
  • BioMérieux - Microbiology clinical trials area coordinator

    MARCY-L'ETOILE 2006 - 2010 Coordination of clinical trial projects in microbiology:

    > Support for the design of clinical trials
    > Validation of clinical trial protocols and reports
    > Elaboration of provisional bugdets
    > Coordination of internal interfaces (program directors, R&D experts)
    > Tools implementation for practices improvement

    Management activities:

    > Functional reporting of clinical scientists
    > Training and management of clinical scientist trainees
  • BioMérieux - Clinical trial manager

    MARCY-L'ETOILE 2004 - 2010 Manager for clinical trial projects, i.e. international multicenter clinical studies (Europe, USA, Asia):

    > Design of clinical studies and protocols writing, in compliance with the CE marking, US-FDA and China-FDA regulations
    > Elaboration of informed consents and notices
    > Elaboration of Case Report Forms, in collaboration with physicians
    > Management of submissions to and interfaces with ethical committees (CPP) and other authorities (CCTIRS, CNIL, ANSM)
    > Selection and qualification of clinical trial sites
    > Settng-up, follow-up, analysis and reporting of results
    > Reports writing and Design Reviews presentations

Formations

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