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Stéphane DUBOIS

Suresnes

En résumé

My Main role is currently to ensure a smooth implementation and follow up of clinical studies at the operational level in compliance with accepted constraints of quality, time and budget.
- Plans and pilot clinical studies (quality, time, cost integrated CRO / fees /reviews / advertising ...).
- Management of the studies through the worldwide clinical operation actors, mainly the local project managers (internal or from CRO): Functional leader of local responsible of studies.
- Provide hierarchy with Scientific and operational feedback (reporting activities).
- Responsible of feasibility studies (at country and center levels): build questionnaires, lead process and analyses of the results.
- Representative of Clinical Operation in committee meetings of studies.
- Management of subcontracted monitoring activities: from the tender for the management of international CRO in collaboration with the Purchase and Legal Departments.
Organization and management of monitoring meetings (CRA and Project managers)

Mes compétences :
Pharmacie
Gestion de projet
MBA
Santé
Communication
Informatique
Industrie pharmaceutique
Management
essais Cliniques

Entreprises

  • Servier - International Project Manager - Clinical Operations

    Suresnes 2014 - maintenant Biologic Agent - Orphan disease area (in charge of 4 phase III studies). Partnership with US company (based in San Franscico)

    Main role is to ensure a smooth implementation and follow up of clinical studies at the operational level in compliance with accepted constraints of quality, time and budget.
    - Plans and pilot clinical studies (quality, time, cost integrated CRO / fees /reviews / advertising ...).
    - Management of the studies through the worldwide clinical operation actors, mainly the local project managers (internal or from CRO): Functional leader of local responsible of studies.
    - Provide hierarchy with Scientific and operational feedback (reporting activities).
    - Responsible of feasibility studies (at country and center levels): build questionnaires, lead process and analyses of the results.
    - Representative of Clinical Operation in committee meetings of studies.
    - Management of subcontracted monitoring activities: from the tender for the management of international CRO in collaboration with the Purchase and Legal Departments.
    Organization and management of monitoring meetings (CRA and Project managers)

  • Servier - International Clinical Study Manager

    Suresnes 2011 - 2014 Metabolism division, in orphan disease area - Biologic Agent
    Writting and validation of protocol
    Offer to tender, choice of CRO, set up of study and management of CRO for central laboratory and IRS.
    writting of study documents (Standart Operating Procedure study specific, study forms, study guides...).
    Set up of study, meetings (monitors and investigators)
    Management of 1 phase II and 3 phase III

  • Servier - International Clinical Study Manager

    Suresnes 2008 - 2011 Set Up of Morbi-mortality study in cardio vascular area (48 countries, 1100 centres, 12 000 patients (planned))
    Validation of main study protocol, written of ancillary protocol (quality of life / PRO sub-study)
    Set up of sub-study (license, tools ...)
    Validation of Feasability (country and site level)
    Set up of IRS (offer to tender, selection of CRO, validation of project requirement specification...)
    Set up of Therapeutic Units

  • Servier - International clinicat study manager

    Suresnes 2005 - 2008 Management of IRS and Therapeutic Units on a morbi-mortality Study in cardio vascular area(34 countries - ~11 000 patients)
    Management of ancillary studies
    Centralized monitoring (monitoring report review)
    Centralized medical review
    Freeze of database, results analysis
    Set up of clinical report appendices (management of two persons on digitization of all documents)
    Validation of clinical report

  • Pharmacie de l'Eglise - Pharmacien étudiant / assistant

    2001 - 2005 Dispensation of medication to patient
    Management of Stock, order to labratories
    Management of trainnee

Formations

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