Mes compétences :
Management
Project
Essais cliniques
Pharmacien
In Vitro Diagnostic
Entreprises
BioMérieux
- Head of clinical project management group
MARCY-L'ETOILE2010 - maintenantHead 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'ETOILE2006 - 2010Coordination 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'ETOILE2004 - 2010Manager 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
