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Harold COUCHOUX

LYON

En résumé

Chef de projet combinant une expérience CRO (Senior et Lead Start-Up specialist) et laboratoire (sociétés de biotechnologie). Compétences transversales en recherche fondamentale, cadre réglementaire des essais cliniques (ICH-GCP), réglementations UE et USA, coordonnation des activités opérationnelles (de la mise en place à la clôture des essais). Anglais courant.

Mots-clés : Opérations Cliniques, réglementaire, ICH-GCP/BPC, coordonnation de projet

Mes compétences :
Anglais
Attaché de recherche clinique
Audition
Biologie
Physiologie
Recherche
Recherche clinique
Clinical study start-up
Développement clinique
physiology
clinical study design
Microsoft Office
Gastroenterology
Data Management
Cardiology

Entreprises

  • Alizé Pharma - Clinical Development Manager

    2017 - maintenant * Elaboration of the global development strategy of medicinal products ;
    * Supervision of the elaboration of the scientific rationale and clinical study design ;
    * Study documents (Protocol, IB, Informed consents) writing ;
    * Selection, management of external vendors (CRO, eProviders, CMO)

  • Medpace - Senior et Lead Coordinateur Soumissions Réglementaires, Study start-up

    2013 - 2017 - Site management;
    - Investigator/hospital/association clinical study agreements, submission to medical board (CNOM);
    - Informed consent form review and approval
    - Regulatory document collection, review and transmittal approval
    - Adherence to project timelines & expectations
    - Coordination of all Competent Authority and Ethics Committee (EC) tasks required for site IP approval in accordance with local regulations, ICH Guidelines.

  • Medpace - Senior and Lead Study Start-up Coordinator

    2013 - 2017 * Coordination of start-up activities in France and Europe ;
    * Regulatory Submissions to Ethics Committees (EC) and Regulatory
    Authorities (RA)
    * Primary contact with sites, CRAs, Sponsors and external vendors (CROs)

  • TBF Tissue Engineering - Clinical Project Manager

    Mions 2010 - 2013 Management of 2 Phase III (Advanced Therapy Medicinal Product) + 2 phase II (tissue) trials in France and abroad
    - Monitoring: Europe/France: assure compliance of collected data with all protocol requirements
    Trainings: Site initiations in France and abroad
    - Regulatory documentation: Assure compliance with State regulations, ICH/GCP guidelines and SOPs
    - Regulatory submissions to Ethics Committees and Regulatory Authorities
    - Implementation of study-related documentation (TMF, e-CRF)
    Data handling: Assure timely and accurate completion of Data Clarification Forms (DCFs)/Queries
    Reports: Completion and submission of visit reports according to SOP requirements.
    Maintenance of awareness of key study performance indicators for own sites (patient enrollment)
    Safety reporting to EC, Competent authorities, EudraVigilance WEB (EVWEB)
    Documentation and tracking of the resolution of all site-specific protocol-related issues from visit to visit

    Contact and coordinating person for a Japanese Biotechnology company
    Validation of feasibility of a phase II clinical trial (over 15 countries):
    - Communications: privileged contact person for a German CRO and a Japanese Biotech company
    - Logistics: in charge of organizing all logistics aspects (transports, timelines...) and validating study documentation in collaboration with CROs for an Phase II Clinical Study.

  • Emory University - Postdoctoral Research Fellow

    Thiers 2008 - 2010 * Research in inner ear physiology

  • Emory and Iowa City Universities, Physiology and Pharmacology Departments - Post doctorant

    2008 - 2010 Postdoctoral fellow, Science Project: study of proteins involved in calcium homeostasis of the inner ear, Ear Physiology
    Biology of the inner Ear training in Marine Biological Laboratory, Woods Hole, MA, USA

  • Claude Bernard University - PhD Student & Teacher

    2003 - 2008 * Research in skeletal muscle physiology

    * Taught BSc and MBSc students about general physiology (cardiac, muscle, GI tract) and cellular and
    molecular biology ,

Formations

Annuaire des membres :