Isabelle Douville

Clinical Project Manager at Bioprojet
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Contact Information
us****@****om
(386) 825-5501
Location
France, FR

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Experience

    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical Project Manager
      • Oct 2021 - Present

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Project Manager
      • Apr 2017 - Sep 2021

  • Hays Life Sciences, for Roche Clinical Operations France
    • Boulogne-Billancourt, Île-de-France, France
    • Project Manager Clinical Studies
      • May 2015 - Apr 2017

    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Project Manager Clinical Studies
      • Jul 2001 - May 2015

      In Oncology and Haematology: * Management of I and III studies in Head and Neck cancer * Management of phase I studies in Haematology * Management of phase II and III studies in Breast cancer * Writing of amendments * Conception of Case Report Form * Realization of provisional budget * Selection of investigational centers, organization of set-up meetings and initiation visits * Training of affiliates Clinical Research Associates and CROs and coordination of their activities * Regular contacts (phone call, monitoring visits) with the participants from the investigational site (local CRAs, investigators, pharmacy, laboratory) * Management of registrations with the strict application of study protocols * Follow-up of therapeutic batch shipments * Validation of the Case Report Form and analysis of the data * Writing of final study reports, publications, abstracts * Checking of files, with a view to archive and prepare the AMM file Show less

  • ASCOPHARM for AVENTIS Laboratory
    • Antony (92) and Paris (75)
    • Project Manager Clinical Studies
      • Jan 1999 - Jul 2001

      In Oncology: * Writing of protocol (phase II study) * Conception of the Case Report Form * Realization of provisional budget * Training and coordination of affiliates Clinical Research Associates * Realization of registrations for a multi-centric and international randomized phase III study * Validation of the Case Report Form and analysis of data * Writing of final study report In Oncology: * Writing of protocol (phase II study) * Conception of the Case Report Form * Realization of provisional budget * Training and coordination of affiliates Clinical Research Associates * Realization of registrations for a multi-centric and international randomized phase III study * Validation of the Case Report Form and analysis of data * Writing of final study report

    • Clinical Research Associate
      • Jan 1997 - Jan 1999

      In Cardiology and Neurology: • Logistical aspect of multi-centric and international studies (phase II and III) in relation with the study clinical manager • Administrative preparation, initiation, monitoring and closing of studies • Preparation and realization of 2 audits In Cardiology and Neurology: • Logistical aspect of multi-centric and international studies (phase II and III) in relation with the study clinical manager • Administrative preparation, initiation, monitoring and closing of studies • Preparation and realization of 2 audits

    • Clinical Research Associate
      • Sep 1994 - Jan 1997

      In Oncology: • Organization of the studies in the department with the medical personnel * Filing in the Case Report from patient’s file • Review and management of CRFs corrections with the laboratories CRAs In Oncology: • Organization of the studies in the department with the medical personnel * Filing in the Case Report from patient’s file • Review and management of CRFs corrections with the laboratories CRAs

Education

  • Faculty of Clermont-Ferrand I
    D.E.A. "Nutrition and Sciences of Aliments"
    1996 -
  • Faculty of Montpellier II
    Master’s and Bachelor’s degree in Biochemistry
    1994 -

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