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J K

SOPHIA ANTIPOLIS

En résumé

Mes compétences :
Terapeutic areas: oncology-cardiology-Dermatology-
Interventional and observational studies
Phase I to IV
SOPs updating
Budget development process
CRAS and providers management
Drugs & medical devices
National and international studies

Entreprises

  • Blue-Reg Pharma Consult -  ATU Project Manager

    SOPHIA ANTIPOLIS 2016 - maintenant

  • Fovea Group (for a Dermatological Laboratory) - Clinical Project Manager

    2015 - 2016 - Coordination and follow-up of clinical studies
    - International regulatory submission process AC/EC
    - Quality control of clinical studies and regulatory compliance
    - Follow-up of budget and logistic
    - Assistance with writing documents required to the study
    - CRAs reports validation
    - CRA training , Investigator meeting, SSRP meeting participation
    - Management of preferred provider

  • Laboratoires Genévrier - Clinical Project Manager

    ANTIBES 2012 - 2015 Medical Devices, drugs, Advance therapy
    Therapeutic areas : rheumatology, dermatology, gynecology

    - Coordination and design of interventional and observational studies
    - Budget development process
    - Writing protocols and all documentation required to the study (investigator brochure, CRF...)
    - Writing clinical reports
    - International and National regulatory submission process (AC/CE)
    - Selection and management of providers
    - Selection of investigational sites,
    - Study start-up,
    - Vigilance management,
    - Updating SOPs

  • Laboratoires Genévrier - Senior Clinical Research Associate

    ANTIBES 2010 - 2012 Interventional studies phases II, III
    Medical Devices, drugs, Advance therapy
    Therapeutic areas : rheumatology, dermatology, gynecology

    - Selection of investigational sites
    - Site qualification, initiation, monitoring (CRF, eCRF) and close-out visits
    - Queries management
    - Supplies management,
    - Safety management (AEs/SAEs),
    - Writing of informed consent, newsletter, CRF, monitoring guideline,
    - Investigator contracts, hospital contracts and fees management,
    - Interaction between Regulatory affairs, quality insurance and biotechnology department
    - CRAs management

  • AMITIS S.A - Clinical Research Associate

    2007 - 2010

  • ANED (Association for the study of Dermatology, France) - Clinical Research Associate

    2006 - 2007

Formations

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