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Sankoung MINTE

PARIS 75008

En résumé

Mes compétences :
Clinical research
ECRF
IVRS/IWRS/IRT
Clinical Regulatory Submission
Submission file preparation
Clinical Project Management
Clinical Research Associate
Project Management
Clinical Trial coordinator
Clinical Trial Monitoring

Entreprises

  • AB-Science - CRA Cordinator

    2015 - maintenant

  • Business & Decision - INTERNATIONAL CLINICAL STUDY COORDINATOR

    Courbevoie 2014 - 2015 Management of 1 Multinational phase III study (3 countries) - Neurology
    • Regulatory submissions,
    • Review of study documents (Protocol, Consent forms, Patient cards…),
    • Edition of Monitoring guides,
    • Preparation of study Initiation Visit (PowerPoint presentation, ISF documents…),
    • Ensuring that projects are progressing according to quality standards, Standard Operating Procedures, ICH-GCP and/or other guidelines,
    • Management of Therapeutic units.

  • Business & Decision - INTERNATIONAL CLINICAL STUDY COORDINATOR

    Courbevoie 2012 - 2014 Consultant for SERVIER LABORATORIES

    Management of 3 Multinationals phase III studies (20 countries) and 1 phase II study (2
    countries) - Ophthalmology
    • Regulatory submissions,
    • Initiation visits for phase III studies (Turkey, Tunisia),
    • Ensuring that projects are progressing according to quality standards, Standard Operating Procedures, ICH-GCP and/or other guidelines,
    • Implementation of Correctives And Preventives Actions (CAPA) following an audit in one site (phase II study),
    • Follow-up of sites closures process (phase II study),
    • Management of Therapeutic units and laboratory kits (from onsite delivery to destruction of remaining materials),
    • Edition and review of study documents (Protocol, Consent forms, Patient cards, Patient diaries, Monitoring reports, Problem lists…),
    • Coordinating activities of several actors (CRO, Laboratories, CRAs …),
    • Finances (Local laboratory fees, CRO fees, investigators fees).
    Monitoring of phase II study in field of ophthalmology – Fatima Bourguiba Hospital -Tunisia
    Monitoring of phase I-II study in field of oncology – Gustave Roussy Institute of Cancerology
    (Villejuif) - France

Formations

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