Brigitte Boucher Email & Phone Number

Paris

Trainer at Supsanté for the Project Managers (PM) training sessions: modules ‘’Vendors’’, Site initiation, Audit/FDA inspections, site closure

Paris Area, France

Global project manager for a Phase III (allergy) phase I (vaccine)

Ile De France

- Worldwide phase 3 study in allergic rhinitis in Europe (Belgium, Bulgaria, Czech Republic, France, Germany, Italy, Poland, Slovakia, Spain), US , Canada, Russia and Israel .Oversignt of vendors.

Île-De-France, France

TA: Rare diseases. Global clinical project manager (Lead ClinicalOperational Manager) on a Genzyme study (phase 2, rare diseases ) conducted in EU, Latam and US.Oversignt of vendors (PK, biomarkers, central medical imaging, central Lab, experts, shipment and storage of samples..).Lead of CTTs....Project Manager on Phase III .

St Germain En Laye

European clinical trial on IMP (Phase III) conducted in 7 countries, 16 sites and 144 patients. Therapeutic area: cell therapy treatment for knee cartilage defect.Key responsibilities:- Operational management and others cross-functional departments and propose corrective/preventive actions- Development of study trackers to monitor study progress - Perform Ethics Committee submissions in all countries and ensure all needed authorizations- Ensure TMF/ISF accuracy and completeness - Site audit support: preparation and corrective action plan - CRA interviews, CRAs assessments

Villepinte

- Management, training, oversight of CROs (lead CRAs, CRAs Covance for US, Latin America and south Corea), meetings on study progress (with CRA Guerbet, lead CRAs Covance).....- Feasability of sites, discussion of study design....