Isabelle Douville
Clinical Project Manager at Bioprojet- Claim this Profile
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Experience
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Bioprojet
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France
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Project Manager
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Oct 2021 - Present
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Stallergenes Greer
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Clinical Project Manager
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Apr 2017 - Sep 2021
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Hays Life Sciences, for Roche Clinical Operations France
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Boulogne-Billancourt, Île-de-France, France
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Project Manager Clinical Studies
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May 2015 - Apr 2017
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Pierre Fabre Group
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Project Manager Clinical Studies
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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
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ASCOPHARM for AVENTIS Laboratory
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Antony (92) and Paris (75)
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Project Manager Clinical Studies
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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
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CLI Pharma for BOEHRINGER INGELHEIM France
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Région de Reims, France
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Clinical Research Associate
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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
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Hospital Jean Perrin under the responsibility of head of the department - Professor Chollet
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Région de Clermont-Ferrand, France
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Clinical Research Associate
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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
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Education
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Faculty of Clermont-Ferrand I
D.E.A. "Nutrition and Sciences of Aliments" -
Faculty of Montpellier II
Master’s and Bachelor’s degree in Biochemistry