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Michael LOUBATON

Courbevoie

En résumé

Eleven years of in-depth experience in the field of eClinical Systems Implementation and Support with broad understanding of the regulation that govern Clinical Research.

As Project Manager and Subject Matter Expert for the IRT System, I am involved in the Study Setup following specialties below. I keep in mind key milestones, systems availability and quality service are primordial for the success of Studies.

Actively seeking new opportunities with a particular interest in the next generation of Systems, I am very motivated to get in touch!

Specialties
• System Selection
• Kick-off Meeting
• Requirements
• Study Build
• Internal Validation
• UAT
• Training Material
• Investigator Meeting Presentation
• EDC/IRT Interactions
• Follow-up Issues

Certification June 2014
MOOC Project Management dispensed by Dr. Remi Bachelet
Ecole centrale of Lille, France
Acquired badges available here: http://goo.gl/ssyF6T

Mes compétences :
Gestion de projet
Industrie pharmaceutique

Entreprises

  • Business & Decision - IRT/EDC Project Manager

    Courbevoie 2013 - maintenant Consultant

  • Pfizer - IRT Project Manager

    Paris 2010 - 2013 Primary Contact for the EU Clinical Project Management Group concerning IRT requests
    Review Design Specification, IRT Requirements & UAT developped by the selected vendor for Vaccine Studies
    Update IRT Templates for Legacy Wyeth Studies migrated in the Pfizer System
    Involved in the decommision of the Wyeth IRT Tool
    Develop Knowledge Base & Processes for the Support Activity
    Training & Supervision of Outsourced Support Agents
    Meetings with System (IRT, EDC, CTMS, Reporting...) Owners

  • Wyeth - IRT Project Manager

    2009 - 2010 Provide Support & Expertise to select Insourced or Outsourced Randomization Systems at Study Start.
    Develop System Requirements, User Guides & User Acceptance Testing Documents.
    Liaise with the Clinical Team, Supplies Management, EDC Team and Vendors for Study Setup
    Develop Knowledge Base & Processes for the Support Activity
    Training & Supervision of Outsourced Support Agents
    Meetings with System (IRT, EDC, CTMS, Reporting...) Owners

  • Wyeth - EClinical Support Analyst

    2004 - 2009 Provide Analysis on complex randomisation and treatment assignment Issues
    Support to CRAs for completing Visit Reports in the inhouse system
    Administration of site personnel in the CTMS system
    Creation of the IRT (IVRS/IWRS) Material
    Presentation of the IRT to the Investigator Meetings
    Training of the IRT System for New Employees

  • Lundbeck - In-house Clinical Research Assistant

    ISSY LES MOULINEAUX 2003 - 2004 Coordination into Phase IV Clinical Trial
    Validation of Clinical data
    Tracking and Analysis of included patients
    Notification of CAEs (Cardiac Adverse Event)

  • Aventis-Phama - Internship of Clinical Research Assistant

    2003 - 2003 Coordination into Phase III Clinical Trial
    Validation of Clinical Data
    Wording of IRFs (Information Request Form) / Tracking and Analysis of IRFs
    Quality-Control into Conciliation Activity
    Co-Monitoring Visit

  • Aster-Cephac - Volunteer Recruitment Associate

    2001 - 2001 Use of volunteers data base
    Selection of potential volunteers into Phase I Clinical Trials
    Phone calls to volunteers regarding upcoming Clinical Trials
    Checking of payments made to volunteers

Formations

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