Sandrine KAHI


En résumé

Mes compétences :


  • NEOVACS - Clinical Project Manager

    2011 - maintenant
  • INSERM SC 10 Clinical Trial Unit - Clinical Research Manager

    2005 - 2010 National and international clinical trials (all phases) in infectious diseases (HIV, Hepatitis, Sepsis, Meningitis)

    Management and coordination of all European clinical sites participating in 2 clinical trials in neonatology.

    - Site initiation visits in all participating sites
    - Coordination of sites (clinical site, pharmacy, laboratory)
    - Supervision of submissions to regulatory authorities and ethic committees, budget establishment
    - Protocol finalization, informed consent form writing
    - Supervision of e-CRF conception and all study procedures and tools
    - Study drug tracking, specimens’ shipment, SAE notification, MedDRA coding, procedures and study documents writing
    - Coordination and management of dedicated team : data managers, local CRA supervision and training
    - Communication with sponsor : reporting, timelines and progress (teleconferences, face-to-face meetings)
    - Cooperation with statistician for data analysis
    - Presentation of results to scientific committees

    Languages: French (mother tongue), English, Italian and Spanish
  • INSERM SC-10 - Clinical Research Associate

    2002 - 2005 * Phase III international clinical trial – HIV infection (180 patients – 48 sites):
    - Monitoring (follow-up and close-out visits) of French, Spanish and Portuguese sites
    - Data capture and queries’ resolution


  • Université Paris

    Paris 2002 - 2003 Methodology and regulations of clinical trials

    Inter university degree : Training of investigators to clinical trials
  • Université Lyon 1 Claude Bernard

    Villeurbanne 1997 - 1999 T cell responses of children congenitally infected by toxoplasma gondii

    PhD in Human Biology