-
Chiltern International
- Clinical Team Manager
Slough
2015 - maintenant
Responsible for managing the Clinical activities for assigned project(s). The Clinical Team Manager, in concert with the Project Leader (PL), is accountable for time, finance, and risk management on his/her allocated project(s).
Line management, Project Lead, Revenue assessment , team allocation oversee, cross project work.
-
Theorem Clinical Research
- Clinical Team Manager
2015 - 2015
Responsible for managing the Clinical activities for assigned project(s). The Clinical Team Manager, in concert with the Project Leader (PL), is accountable for time, finance, and risk management on his/her allocated project(s).
Line management, Project Lead, Revenue assessment , team allocation oversee, cross project work.
-
Theorem Clinical Research
- LEAD CRA
2014 - 2015
Responsible for managing the Clinical activities for assigned project(s). The Lead CRA, in concert with the Project Leader (PL), is accountable for time, finance, and risk management on his/her allocated project(s).
-
BIOFORTIS - Mérieux Nutrisciences
- Clinical Operation Manager
2011 - 2014
Biofortis is an international full service CRO specialized in health nutrition, with a proper investigational center, we could propose monocentric studies, as well as international multicentric studies, my role within Biofortis is to:
• Ensure the operational and logistical implementation of clinical studies managed within Biofortis in accordance with existing procedures and ICH-GCP.
• Resource Management, budgets assessment and management,
• Oversee the clinical operation team: Project Managers, CRA and Clinical Research Assistants
• Supervise all studies at the operational level in relation with Project Managers.
-
ICON Clinical Research
- Sr CRA Decentralized
2011 - 2011
-
ATLANSTAT - Nantes
- Project Manager/Clinical Trial Coordinator
2008 - 2011
• Coordination de plusieurs projets, en infectiologie, gastroentérologie et orthopédie (DM), de la sélection à la fermeture
• Rédaction de protocole, des documents réglementaires, soumission aux Autorités Réglementaires
• Gestion et Management des ressources, estimation et gestion des budgets
• AQ : Mise à jour et création des procédures opérationnelles Opérations Cliniques
-
Parexel International
- Clinical Research Associate
Paris
2005 - 2008
• Responsable de plusieurs études internationales de phase I à III (Lymphome Non-Hodgkinien, Sarcomes, Colite Ulcéreuse…) pour la France et la Suisse :
• Support au département médical pour les soumissions aux autorités réglementaires (France, Suisse, Belgique),
• Activités de sélection, initiation, monitoring et fermeture,
• Gestion des TMF, mis à jour des documents réglementaires.
-
Ascopharm
- Clinical Research Associate
Апатиты
2003 - 2005
Activités de monitoring (sélection, initiation, monitoring et fermeture) sur plusieurs études, gestion du TMF, des demandes de corrections :
- étude de phase III en cancer du sein (20 centres, 500 patientes)
- plusieurs études de phase III et IIIb en transplantation rénale (15 centres, 180 patients).
- étude de phase II en cancer du sein métastatique (10 centres, 200 patientes).
-
CRLCC Paul Papin
- Clinical Research Associate
2002 - 2003
