Géraldine GUIRONNET
Clinical Operation Leader
Rillieux-la-Pape
Vue d'ensemble
24
24
years of professional experience
8
8
years of post-secondary education
Expérience
Clinical Operation Leader
Sanofi
Marcy-l'Étoile
01.2021 - 11.2024
- Clinical Programs’ primary R&D Project Team member.
- Management of global clinical development programs from ph I through licensure.
- Develop, critically assess, and evaluate feasibility of the Clinical development plan in collaboration with the Global Clinical Development Expert and Clinical Franchise Leader.
- Support the clinical project strategy by providing expertise to develop the best operational strategy
- Review, negotiate, and support execution of required legal agreements for activities supporting the clinical program.
- Identify and pursue opportunities for improving processes.
- Provide guidance on best practices and lessons learned for execution of clinical trials.
Global Trial Operation Manager
Sanofi-Pasteur
Marcy-l'Étoile
09.2018 - 12.2020
- Represents & supports Clinical Programs at study level, collaborating actively with all functions in Clinical to get optimized deliverables.
- Coordination of Flu Vaccine Chinese Studies (phases I&III) and MenB studies (phI&II)
- Management of studies Timelines, Budget, Risks
- Reporting to upper mamangement
Lead Clinical Trial Manager (late Phase studies)
Sanofi
Chilly-Mazarin
05.2012 - 08.2018
- Management of international medico-marketing, phase IV studies (from Protocol review to Clinical Study Report)
- Responsible for the operational planning and activities for the implementation and conduct of studies in compliance with GCP's, SOPs and standards within established timelines and budgets.
- Involvement in the scientific conduct of the study and act as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other study department representatives.
- Coordination and support of monitoring teams worldwide
- Coordination and supervision of external vendors such as central lab, IVRS, eCOA vendors (preparation of request for proposal, review vendors specifications, contracts review, costs estimation, collaboration with the Purchasing department)
- Budget management
- Protocol review and CRF creation
- Meetings preparation and presentations including CRA trainings and investigators meetings
- Development of study specific procedures and operational documents
- Patient data validation
- Involvement in working groups for process development
- Preparation and participation to audits
- therapeutic areas: rare disease, multiple sclerosis, cardiology...
International Clinical Trial Manager
Sanofi
07.2005 - 01.2011
- Management of international ph II & III studies (cardiology)
- Responsible for the overall operational planning and activities for the conduct of clinical studies
Clinical Trial Manager
Alios Conseil
Chilly-Mazarin
06.2004 - 06.2005
- Responsible for the overall operational planning and activities for the conduct of big International Phase 3 clinical trials (in Cardiology)
Clinical Study Manager
Laboratoires Servier
09.2002 - 02.2004
- Toxicological studies oversight. Management of ph I & II studies.
Project coordination in Research
4C Biotech (Belgium)
01.2001 - 12.2001
- Coordination of Research Projects (stem cells)
Formation
Clinical Research Associate -
Sup Santé
01.1999 - 12.2000
Industrial Systems Management - undefined
UCBL
01.1999 - 12.2000
PhD in Immunology & Dermatology - Human skin and Immunity
UCBL
01.1997 - 12.2000
Compétences
- Project coordination
- SCRUM method
- Clinical studies coordination (ph I to IV)
- Timelines and budget management
- Risks management
- CRO oversight
- Negociation
Informations complémentaires
- Pratique de la course à pied
- Yoga
- Musique (chorale, violon...)
Langues
Anglais
Courant
Allemand
Notions
Chronologie
Clinical Operation Leader
Sanofi
01.2021 - 11.2024
Global Trial Operation Manager
Sanofi-Pasteur
09.2018 - 12.2020
Lead Clinical Trial Manager (late Phase studies)
Sanofi
05.2012 - 08.2018
International Clinical Trial Manager
Sanofi
07.2005 - 01.2011
Clinical Trial Manager
Alios Conseil
06.2004 - 06.2005
Clinical Study Manager
Laboratoires Servier
09.2002 - 02.2004
Project coordination in Research
4C Biotech (Belgium)
01.2001 - 12.2001
Clinical Research Associate -
Sup Santé
01.1999 - 12.2000
Industrial Systems Management - undefined
UCBL
01.1999 - 12.2000
PhD in Immunology & Dermatology - Human skin and Immunity
UCBL
01.1997 - 12.2000
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