Fabrice DOMITIEN

En résumé

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

  Paris 2011 - 2012 Coordination 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

  Durham 2008 - 2011 Review 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 - 2008 Coordination 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

  2004 - 2004

Formations

• Université Paris 13 Paris Nord Villetaneuse

  Villetaneuse 2002 - 2003 Information and Communication

• Université Paris 13 Paris Nord Villetaneuse

  Villetaneuse 2002 - 2004 Information et communication

Réseau

• Cédric FROGER

• Hassan EL YAACOUBI

• Ivana IVCEVIC

• Karine DEMIGNÉ

• Laura MICHAUD

• Laurianne ROUET

• Marie SOMPHANTHABAMSOUK

• Myna YEBOAH

• Ophélie CAZANOVE

• Thomas HUCHON