Laurence DESOMBRE

En résumé

Entreprises

• AB Science - Director Clinical Operations and Quality

  2012 - 2013 Planning 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 - 2009 Created 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 - 1999 Led 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 - 1996 Responsible 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 - 1993 Responsible 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 - 1988 Responsible 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

• O.S.I. (Omnium Scientifique Industriel) - Sales representative and Junior Product Manager

  1984 - 1987 Sales 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 - 1984 Study 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

Formations

• Université Paris 7 (Denis Diderot), Jussieu

  Paris 1982 - 1983 DEA (Specialised Doctorate) in Human Genetic and Anthropobiology
  
  Human Genetics, Biostatistics, Anthropology

• Université Paris 7 (Denis Diderot), Jussieu

  Paris 1981 - 1982 Master of Organisms and Populations
  
  Human Biology, Human Genetics, Biostatistics, Biochemistry, Ecology, Zoology

• University Of Rhode Island (Kingston)

  Kingston 1980 - 1981 Bachelor of Science
  
  Biology - One year exchange program between University of Orléans (FR) and University of Rhode Island (RI, USA)

Réseau

• Aldjia AIT ALAMARA

• Anne LERMET

• Aurélie LEGAY

• Corinne ALBERT (CHAMLA)

• François MONTESTRUC

• Lise BARBIN

• Maxime BLONDEAU

• Mina LOUAHDI

• Sarah HORN

• Thibault ERNST