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Experiences

Current Experience

  • Scientific Project Manager Medical Affairs
    Since January 2015
    Coordination of Investigator/Institution Initiated Research in Oncology (phase I/II/III)  - Scientific communication with KOL - Regulatory and scientific expertise for KOL’s clinical projects  - Management of medical products supply – Budget monitoring - Financial contract  - Competitive and scientific intelligence Scientific and regulatory support/expertise for internal department (Market access, Medical Affairs, Pharmacovigilance…) and external partner (KOL, Investigators, service provider…) Post-Marketing Studies : Non-interventional real-life studies (phase IV), PASS (Post-Authorization Safety studies), Database studies (SNIIRAM, EGB database)  - Project management related to the medical plan  -¨Protocol writing  - Regulatory submission to legal authority (Data protection legal department - CCTIRS/CNIL/CNOM)  Vendors management: CRO, communication company  Budget planning and financial expertise/follow-up  Management of initiation and quality review activities

Past Experience

  • Scientific Advisor/Coordinator CNS
    September 2010 --- January 2015
    - Promotion of clinical studies in line with hospital strategy and medical plan in Neurosciences - Communication with KOL of cutting-edge scientific/medical information (face to face, staff meetings, local events), scientific and medical referent for target diseases - Supervision of clinical operation : Management of a team of CRA (6-10 persons) - Coordination (regulatory, financial, scientific and operational) of clinical studies (phase I, II, III, IV studies) - Project Management : development of a scientific and medical communication plan - Management of hospital and investigator contracts department - Scientific and regulatory expertise and support for clinical research activities - Protocol and study documents writing - Competitive and scientific intelligence - Contact point with legal authority and ethics committee - Support and train internal partners - Quality process : writing and review of standard operational procedures

  • Senior Clinical Research Associate (CRA)
    April 2007 --- September 2010
    Initiation, Monitoring of international multicentrique clinical studies (phases I, II, III) mainly in oncology and neurology, gastro-enterology occasionnaly. Home-based position during one year

  • Clinical Research Associate (CRA)
    April 2006 --- April 2007
    Regulatory submission (ethics committee, legal authority) Contracts Initiation, monitoring and closure of national multicentrique clinical studies (breast cancer only)

Knowledge

LinkedIn Assessment :
Essais cliniquesRecherche cliniqueBonnes pratiques cliniquesOncologieCROSecteur pharmaceutiqueCIH - BPCSciences de la vieInformatisation des essais cliniquesDéveloppement cliniqueAffaires médicales

Education

  • PhD in Biologie cellulaire et moléculaire from Université Paris Sud (Paris XI) in 2005

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
French
Native

Area / Region

Lille, France

Others

Driving License
  • Yes