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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  -¨science)" rel="nofollow">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 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 - science)" rel="nofollow">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 pharmaceutiqueCIHSciences de la vieInformatisation des essais cliniquesDAffaires m

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

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