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Sonia SAAI

VALLAURIS SOPHIA ANTIPOLIS

En résumé

Over 18 years of experience in clinical research, starting at the university hospital, as a clinical research associate, and subsequently in medical device companies. My various positions within companies allowed me to evolve from the position of project manager to currently head of clinical affairs with a managerial activity in clinical operations, clinical evaluation and quality assurance.

Mes compétences :
Dispositifs médicaux
Gestion de projet
Recherche clinique

Entreprises

  • Oticon medical - Head of Clinical Affairs

    2018 - maintenant

  • Neurelec Oticon Medical - Clinical Trial Manager

    2012 - 2018 Responsible of pre-clinical trials
    - Animal experimentation regulatory requirements, ethic approval and follow-up
    - Advisory role for R&D dpt and literature review to address their needs
    Responsible of all phase of clinical trials
    - Responsible of all aspect of clinical trials
    - Participation in R&D activities participating in products risk analysis
    - Statistical analysis & data valorization (abstracts, posters, presentations)
    - Assisting in the management of legal and operational aspects of our partners clinical trials
    - Protocol design for IDE submission
    - Presentation of trials in progress and planned to the internal sales meetings
    - Staff training
    Post Market activities
    - Maintain PMS file for each product
    - Responsible of study design, CRO contracts and management for a European Registry
    Creation and review of SOPs

  • Ekkyo - Chef de Projet Clinique

    2008 - 2012 Responsible of pre-clinical trials
    - Design, implementation & supervision of preclinical tests (in vitro, ex-vivo)
    - Management of subcontractors (histology and biologics testing)
    Responsible of all phases of clinical trials
    - Project set up and planning
    - Management of timelines and quality deliverables
    - Trial design and implementation : trial dossier, regulatory filings, ethical committee approval
    - Protocol design for IDE submission
    - Selection of sites and training,
    - Start up, monitoring and close-out, final report
    - Budgeting and cost control
    - Statistical analysis & data valorization
    Post Market activities
    - Design and implementation of an E-Registry
    - Protocol design for European distributors (Phase IV and post market)
    - Developing trial protocol, CFRs, informed consents
    - study feasibilities, start-up, monitoring and close-out

  • University Hospital Urology dpt - Clinical Research Associate

    1999 - 2008 National Coordination for a urinary-incontinence medical device:
    - Protocol design for the Sponsor
    - Maintaining an E-Registry
    - Remote monitoring of about 10 sites and queries edition.
    - Check clinical site activities

    Phase II to IV trial management:
    - Pharmaceutics and medical device trials management
    - Ensure compliance with clinical trial protocol
    - Screening and enrollment of subjects
    - Filing trial documentation
    - Liaising with pharmacist
    - Update a Database in prostate oncology
    - Promote clinical data, statistic analysis,manuscripts for publications.
    - Coordinating Central lab & Imaging core lab
    - Training & Information of site staff & CRAs
    - Organizing investigator meetings in France and Europe

  • EDAP-Tms - Clinical Research Associate

    Vaulx-en-Velin 1998 - 1999 Pre-clinical and clinical research:
    - Micro-waves effects on Begin Prostatic Tissue
    o Literature research to evaluate the best animal model
    o Patients tests and follow-up
    - High intensity focused ultrasound in prostatic hyperplasia
    o Data extraction and analysis form

Formations

Pas de formation renseignée

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