Menu

Nicolas HOLLEBECQ

LEVALLOIS-PERRET

En résumé

Mes compétences :
SAEs management
Pharmacovigilance
Microsoft Office

Entreprises

  • PPD - ARC II

    2016 - maintenant
  • Georges Pompidou Hospital - Clinical Research Associate

    2013 - 2016 Job Functions:
    * National Multicentric, Randomized, Open-label, * Ensure patient safety, quality of data and adherence
    Phase III and IV interventional or not Studies. to the protocol in compliance with SOPs/ GCP and
    * Assist project manager in regulatory submission to local regulatory.
    authorities and ethics committee making. * Drug Safety and Epidemiology: SAEs management
    * Creation of study documents and standard and follow-up.
    operative procedures. * Planning and coordination of critical events
    * Preset investigation centers. adjudication committees. ;
    * Site Initiation visits and hospital staff training. * Queries management (edition and validation). ;
    * Planning meetings for investigators. * Supplies checking (biology, pharmacy services). ;
    * Monitoring visits: paper and electronic Case * Audit preparation (internal and external).
    Report Form (CleanWEB and RedCap).
    * Close out visit, data archiving.
  • Hepatobiliary Centre - Clinical Research Associate

    2013 - 2013 : Clinical Research Associate - Hepatobiliary Centre - Paul Brousse Hospital -
    Biologic simple management, assistance in data collection in consultation, filling in report forms (paper and
    electronic) and databases; participation in CRAs monitors visits.
  • Capsis - Technicien Microbiologique

    LES ULIS 2011 - 2011 Analyses microbiologiques des eaux industrielles

Formations

Réseau

Annuaire des membres :