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Laurence DESOMBRE

COURBEVOIE

Electionseuropéennes 2024

RETROUVEZ GRATUITEMENTLe résultat des européennes à Courbevoie ainsi que le résultat des européennes dans les Hauts-de-Seine.

En résumé

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 - 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

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