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Experiences

Past Experience

  • Senior Clinical Research Associate
    January 2006 --- January 2015
    • extensive monitoring (average of 12 studies at a time) • Clinical Operation Manager back-up responsibilities • Local Ethics submission (phases I and IV) Therapeutic areas: oncology (Colorectal cancer, Prostate, lymphoma, Head and Neck, Breast, Ovarian), tibia fracture, osteoporosis, cardiology, diabetes mellitus - phases I to IV

  • Clinical Project Leader local project management - Australia/NZ
    January 2004 --- May 2006
    • Budget management and set-up • Project management (internal and contracted) • Coordination of internal and external CRAs and Lead CRAs in Australia and New Zealand • Trained CTAs into CRAs, mentored junior staff, wrote local SOPs Therapeutic areas: Breast cancer, cardiology, cirrhotic ascites, diabetes mellitus - phases I to IV

  • CRA Coordinator (Project Management France/UK)
    January 2003 --- January 2003
    Project management - EU: France, UK, Germany Management of the CRAs working on the project (internationally based: France and UK) Responsible for communication with the Sponsor Completed and submitted Ethics Applications. Therapeutic areas: phase II cystic fibrosis - phase IV diabetes mellitus with hypertension and nephropathy

  • Clinical Research Associate (CRA)
    January 2001 --- November 2002

  • CRA coordinator (2000 - 2001) - CRA (1999- 2000)
    January 1999 --- January 2001
    International Project coordination: UK, France, Belgium, Germany, Spain, Italy, Holland, Canada, Australia Coordination of the CRAs working on the project (internationally based) Responsible for communication with the Sponsor Completed and submitted Ethics Applications. Therapeutic areas : Oncology: cell therapy and gene therapy (ovarian, liver, head and neck), cardiology (hypertension) - phases I and III

Personality

Self Assessment :
AdaptabilityEfficiencyFlexibilityProactivityResponsibilityCollaborationCoordination

Knowledge

Self Assessment :
Budget ManagementCancerCardiovascular diseasesClinical DevelopmentEthics submission and approval processICH-GCPInformed Consent ProcessKnowledge of the drug development processWriting Study Procedures and SOPsInformed Consent DocumentsUnderstanding of regulatory guidelinesProject Management

Education

  • maitrise in Recherche Clinique from IUP Ingénierie de la Santé in 1999

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Locations I am interested in:
    France
  • Work From Home:
    Yes, 5 to 0 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Nantes, France

Others

Driving License
  • No