Mes compétences :
Communication
Evénementiel
Coordination de projets
Gestion de projets internes : Management et clôtu
Entreprises
Novartis
- Technicien logistique essais cliniques
RUEIL MALMAISON 2013 - maintenant• Rédaction de procédures, mise en place de nouveaux outils, préparation d’audit et inspection.
• Gestion des produits pour essais cliniques (en développement et commerciaux) : suivi Importation des produits, libération des produits en distribution locale et centralisée, suivi des péremptions et destructions, mise à jour TMF étude, gestion des dossiers de lots.
• Suivi budgétaire.
• Gestion des Contrats/Devis, MSA avec les prestataires.
• Validation étiquetage produits pour soumissions réglementaire.
Sanofi
- Strategic project coordinator
Paris2011 - 2012Coordination and follow up of internal and external projects for G-EVD team ( feasibility of products)
Set up and follow up of Budget events
Participation of negociation, set up and signature process for contracts ( third party, Key opinion Leader)
Creation and set up of communication tools (Newsletter, Posting)
Quintiles
- Site Start up Specialist
Durham2008 - 2011Review and negotiate site regulatory documents with sites for agreement on wording.
· Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
· Review and provide feedback to management on site performance metrics.
· Serve as contact for investigative sites, designated project reports, communications, and customer service.
· Resolve site issues and determine status for product shipment.
· Work with regulatory team members or sponsor to secure authorization of regulatory documents.
· Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and
deliverables.
· Inform team members of completion of regulatory and contractual documents for individual sites.
· May serve as a "Country Owner" for country or region as needed. Coordinate activities for projects within area of
specialization.
· May translate or review completed translations of critical documents.
MDS pharma services
- International Project Coordianator
2005 - 2008Coordination of all study activities from start up to closure
Co-design of study documents, choice of required material, shipment of material to the sites, training of sites and internal other implied departments
Study Monitoring in contact with CRAs and investigators by fax, email and phone
Queries resolution and material’s pick up at the study’s closure
Cap Even
- Coordinateur communication évenementiel
