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Ludovic DYEN

PARIS

En résumé

- Large experience in clinical research in different therapeutic areas (oncology, onco-hematology, ophthalmology, rheumatology,hematology, rare diseases, emergency,alternative therapeutic) and different types (Phase I-IV, health care and non-interventional studies)
- Protocol/ Inform consent and CRF comment
- Clinical Trial set up
- Clinical trial French regulatory process.
Specialties

Management of clinical research project, problem solving attitude, knowledge of French hospital organisation, strong team spirit, team leadership

Entreprises

  • DRCD APHP - Chef de Projet en Recherche Clinique

    2011 - maintenant - Management of 20 studies.
    - Therapeutic area : onco-hematology (LAL), oncology, Surgery, rare diseases (thalassemia), alternative therapeutic (acupuncture)..
    - Biomedical research with or without medicine (Phase II-IV), Medical devices, Health care, non-interventional studies
    - Feasibility. Clinical Trial set up :Protocol, inform consent and budget review, Clinical trial regulatory process (French regulatory authorities, Ethic comity, CCTIRS/CNIL submissions). Patient recruitment rate, study timelines ongoing review. Planning and managing of timelines, Budgets, Resources and People.

  • DOCS International - Senior CRA Outsourcing

    2009 - 2011 - 2 International pivotal studies, phase I-II. 13 French sites.
    - Onco-hematology (Follicular NHL), Virology (HCV)
    - Initiation, monitoring and close-out visit.
    - Follow up tool set up. Reporting. SAE, Data queries, Interim analysis management.
    - Compliance and Audit visit.
    - Site financial management.
    - Archiving.

  • Chiltern International - CRA I, Insourcing

    Slough 2007 - 2009 - 4 International Studies, phases II-III.
    - Onco-hematology, Ophthalmology, Vascular, Rheumatology.
    - Pre-trial, initiation, monitoring visit, Audit. Ethic comity submission. Hospital and investigator contracts. Hospital over-costs and investigator payments process . Data queries, SAE, safety patient review. Timelines and GCP. Reporting. TMF, ISF archiving review.

  • APHP - Clinical research technician

    Paris 2006 - 2007 - Management of 12 studies
    - Prostate, ovarian, liver, lung, colorectal and pancreas cancers.
    - CRF completion, patient visits planning, samples management, help with inclusion/exclusion criteria review. Close work with CRA during monitoring visit. SAE, pharmacovigilance and data queries answer.
    - Improvement of the clinical research department organisation

Formations

Pas de formation renseignée

Réseau

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