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Marion GHIDI

PARIS 11

En résumé

Pharmacist specialized in Clinical Research, I work in a biotechnology company developing innovative therapeutic and preventive products against multi-resistant and life-threatening infections. After 2 years as Deputy Head of the microbiological lab, I manage now the coordination of clinical studies.

Mes compétences :
Clinical Trial
Coordinator
CRO
Infectious Diseases
Manager
Microbiology
Microsoft Project
Data Management
Clinical operations
Project Management
Monitoring
Biotechnology
FIEC
Regulatory Affairs

Entreprises

  • Da Volterra - Clinical Study Coordinator

    PARIS 11 2013 - maintenant • Biotechnologies, drugs / medical devices, phase I-II studies
    • Contribution to study design and writing of study protocol, statistical analysis plan and integrated study report according to ICH
    • Collaboration with KOLs, experts and investigators
    • Participation to selection of CROs and other partners, and discussion of tasks and budgets
    • Preparation of study regulatory documents, submission to / discussion with Competent Authorities and Ethics Committees
    • Management of clinical operations, collaboration with the Project managers, CRAs, Data managers and Statisticians.
    • Study follow-up: writing/approval of operational documents, management of drug and material supplies, organization of biological sample shipment, preparation and maintenance of the Trial Master File, selection and initiation of study sites, supervision of monitoring and data management.
    • Medical and regulatory watch
    • Writing of Standard Operating Procedures
    • Support to other departments (microbiology, pharmaceutical, bioanalytics)

  • Da Volterra - Deputy Head of the R&D Microbiological Laboratory

    PARIS 11 2011 - 2013 • Planning, protocol writing, implementation, interpretation and reporting : microbiological assay, MIC, enzymology, ex-vivo/in vitro studies, preclinical in vivo studies
    • Order management, logistics of the laboratory
    • Scientific and strategic watch (writing of Newsletters)
    • Writing preclinical study protocols
    • Management of laboratory technicians and trainees

  • DSM Nutritional Products France - Head of the Microbiological Quality Control Laboratory, QCA Blend Units

    Village-Neuf 2011 - 2011 • Follow-up and improvement of microbiological assays on end products, raw materials and environment (production areas et laboratory)
    • Management of non-conformities, corrective actions
    • Management of laboratory materials, reagents, security and ergonomics
    • Management of six technicians

  • BioMérieux SA - Professional Master training (6 months), bioMérieux Laboratories, R&D Immunoassay Unit

    MARCY-L'ETOILE 2010 - 2010 Expression and purification of recombinant proteins of high molecular weight:
    - molecular biology
    - bacterial culture
    - production of recombinant proteins
    - purification and characterization of proteins.

  • Pharmacie - Pharmacist (D section of Pharmacist Order)

    2008 - 2009 Fixed-term contract in pharmacy

Formations

  • Université Paris 7 Denis Diderot

    Paris 2013 - 2014 Inter-University Diploma « Training of Investigators for Clinical Trials » (DIU FIEC), Clinical Research, With honors

  • Université De Bourgogne

    Dijon 2009 - 2010 Master 2 MAAA, Professional Master 2: Microbiology for food industry and agri-environment, Microbiological Safety

    With honors

  • Université Dijon Bourgogne Faculté de Pharmacie

    Dijon 2002 - 2008 Doctor of Pharmacy

    Thesis: « Coated stents for treatment of myocardial infarction. Data of the obseRvatory of Infarction in Côte d’Or : RICO », with honors and congratulation of the jury.

Réseau

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