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Carole DELMAS

Boulogne-Billancourt

En résumé

Based in Paris,

Several skills developped in a Pharmaceutical company. That concerns the follow-up and the coordination of Clinical projects , since the outset of a study until the publication of its CSR.

My professional objective is clearly focused towards the Coordination and the Management of Clinical Trials at short-term.

I am currently looking for a job . Available now !

Mes compétences :
Oncology
Pharmaceutical Industry
Project Coordination
SOP
Clinical Trials
ICH-GCP
GCP

Entreprises

  • Ipsen - PROJECT COORDINATION / FOLLOW UP

    Boulogne-Billancourt 2010 - maintenant International Interventional studies (Ph II, III) : Growth disorders - Neurology - Uro-oncology
    Non-interventional studies (Ph IV) :
    International : Oncology - PMR/Neurology - Growth disorders - Follow-up of adults treated with GH
    National : Oncology

    Coordination of Clinical Trials
    Review of Study documents (Regulatory adaptations for France - Translations)
    Regulatory submissions
    Financial agreements (Investigator, Over-costs)
    Coaching of site CRA
    Development of internal and external network (Data Managers / International regulatory / Central Department of PV / Central labs and other providers)
    Co-writing of a local standard operations procedure
    Archiving
    Attendance to Investigators meetings / Congresses

    Follow-up of Clinical Trials
    Feasibility studies - Site pre-selections -Selection visits
    Initiation visits - Monitoring visits - Remote Monitoring - Close-out visits
    On-site logistics
    Management of tables monitoring study progress (Patients / Treatments / Data entry)
    Transmission / Checking of study data with data Management
    Meetings

    Specialities :
    - Oncology - Oncogastroenterology
    - Uro-oncology
    - Physical Medicine and Rehabilitation - Neurology
    - Endocrinology

  • Ipsen - SALES REPRESENTATIVE

    Boulogne-Billancourt 2001 - 2009 Specialities : Primary Care - Cardiology - Gastroenterology - Neurology - Pediatrics - Geriatrics - ENT - Ophtalmology

Formations

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