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Summary

Single Point of Contact for Multiple Clinical Trials in SSU Phase: coordination, contract negotiation, Ethics Committee Submission, Regulatory Authorities Submission, Documents and Logistics, MDEON. Some coaching responsibilities of Junior people. Creation of Study Guidances, regular contact with client.

Experiences

Current Experience

  • Senior Specialist, Global Site Services
    Since April 2013

Past Experience

  • RSU Specialist
    September 2011 --- April 2013
    Single Point of Contact for Multiple Clinical Trials in SSU Phase: coordination, contract negotiation, Ethics Committee Submission, Regulatory Authorities Submission, Documents and Logistics, MDEON, some coaching responsibilities of Junior people. Creation of Study Guidances, regular contact with client.

  • Associate SSU Specialist
    September 2010 --- September 2011
    - Collection of Regulatory Documents and compilation of regulatory packages in preparation of IP-Release and activation of sites. - Contract preparation and negotiation for initial studies or amendments. - Responsible for MDEON Submissions From March 2011: Single Point of Contact for Multiple Clinical Trials in SSU Phase - coordination, contract negotiation, EC Submission, Documents and Logistics, MDEON.

  • SSU Coordinator
    September 2008 --- September 2010
    - Collection of Regulatory Documents and compilation of regulatory packages in preparation of IP-Release and activation of sites. - Contract preparation and negotiation for initial studies or amendments. - Responsible for MDEON Submissions

Knowledge

LinkedIn Assessment :
LanguagesCROICH-GCPContract negotiationRegulatory submissions

Education

  • Engineer in Biochemistry, Biotechnology in Biochemical Engineering from Université libre de Bruxelles in 2007
  • in from crommelynck in 0

Area / Region

Brussels

Others

Driving License
  • No