Mes compétences :
Quality Assurance management
Management of CRAs and Project Managers
Clinical Studies Management
Clinical Operations Management
Audits and Investigations
Entreprises
AB Science
- Director Clinical Operations and Quality
2012 - 2013Planning and management of clinical development plan and clinical quality assurance
• Management of CRAs activities France and USA
• Support to Clinical Project Managers to ensure proper running of clinical studies with allocation of resources and support for submission to competent authorities and ethical committees
• Management of quality assurance: maintain the quality system, provide training to the concerned staff and Control compliance to company SOPs and applicable regulatory requirements (ICH-GCP, EU Directive, CFR...)
Kendle International
- Associate Director Clinical Quality Assurance
2009 - 2011
Laurence Desombre
- Free lancer
2000 - 2009Created successful consultancy serving the health care industry (primarily the medical device and pharmaceutical industries)
• Providing strategic management of clinical studies and registries
• Provision of analytical support in the generation of study results and subsequent publication
• Clinical Quality Auditing of client clinical operations groups, resulting in a strategic plan to reorganize and streamline the standard operating procedures (SOPs) for those groups
Guidant Europe, Brussels
- European Field Clinical Engineers Manager
1996 - 1999Led Field Clinical Engineering group for Europe with budget and personnel management for the eight (8) Field Clinical Engineers
Member of the corporate quality department, representing Europe.
• Set up successfully Investigational Focus Centers (IFC) program around Europe, and implemented use of the quality standards requirements for all studies centres
• Led internal clinical quality audits in Europe and investigators sites, audit performed by US Quality Department; management and coordination of correctives actions and strategic reorganization SOPs/WIs for Europe
SCIMED LIFE SYSTEMS EUROPE
- European Clinical Manager
1993 - 1996Responsible for European clinical studies and clinical quality assurance in close collaboration with the US management teams, R&D, and clinical operations teams
MEADOX MEDICALS INC.
- Senior Clinical Research Associate
1988 - 1993Responsible for clinical studies management in Europe, monitoring of sites, statistical analysis of European studies and report writing, including development of European databases (MEDLOG). Additionally, authored global SOP/WIs (Europe and USA)
RORER INTERNATIONAL
- Clinical Research Coordinator
1987 - 1988Responsible for the setup and monitoring of Phase III studies, as well as the support of other CRAs and participation in the analysis of data and report writing
1984 - 1987Sales Representative: Responsible for Universities, hospitals and research centers, Development of market shares (35% increase)
Junior Product Manager: Biology high technology equipment, responsible for marketing surveys and sales force training
INSERM (Institut National de la Santé et de la Recherche Médicale)
- University Researcher
1983 - 1984Study of Family Transmission Mode of Alzheimer's disease: Extensive searches on pre-senile pathologies and Epidemiology and statistical analysis of family data. Publication of results
