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Experiences

Past Experience

  • Clinical Project Manager (CPM)
    December 2006 --- August 2015

    Domain: Immunology - Rheumatoid Arthritis; CNS - Epilepsy

    • Manage study start-up, conduct and close-out. Co-ordinate efforts of cross-functional project teams to support key deliverables achievement within agreed timelines and according to cost constraints.
    • Develop study tools to ensure the oversight of the study znd ifentify issues proactively, resolve/mitigate and escalate risks and/or issues.
    • Lead rpoblem solving and resolution  efforts to include management of risk, contingencies and issues.
    • Provide project status on a regular basis and ensure appropriate escalation of risks, findings, and action plans to appropriate parties; ensure responses to key decision from appropriate parties.
    • Identify quality issues within the study for implementing appropriate corrective action plans.
    • Request and maintain team assignments; provide input to ine managers of their project team members'performance.
    • Serve as primary project contact with CRO and vendors (central laboratory, IVRS) to ensure communication is maintained and milestones are achieved.
    • Maintenance and update of trial management systems.
    • Review and approval of study documents (protocol, study management plan, monitoring plan ...).
    • Prepare and present project information at internal and external meetings.
    • Coordinate audit responses.
    • Ensure quality and adherence to the relevant Standard Operating Procedures, Good Clinical Practices and Regulatory guidelines.

  • Associate Clinical Trial Manager Brussels, Belgium
    November 1997 --- November 2005

    Domain: Epilepsy

    • Cross-functional study team management, i.e., management of a matrixed team, including Statistics, Data Management, Clinical Research Physician, European Subsidiaries, Regulatory Affairs, Drug supply, Outsourcing and contracts,etc
    • Vendor management (CROs and central laboratories)
    • Responsible for the budget and timelines management
    • Study document generation/review and approval (Protocol, Monitoring guidelines, investigational and vendor contracts)

  • Clinical Research Associate (CRA)
    November 1994 --- November 1996

  • Laboratory Assistant
    November 1983 --- November 1993

Personality

Self Assessment :
ProactivityProblem solvingOrganizationFlexibilityWillingness to compromiseCoordinationAnalytical thinkingAttention to detail

Knowledge

Self Assessment :
BiochemistryClinical operationsClinical trial budgetingComplianceCRF designImmunology

Skills and Expertise

Self Assessment :
Analytical skills

Education

  • Master in psychology from mons Hainaut in 1993
  • Bachelor in biochemistry from Irschonwelz Ath - Belgium in 1982

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency
Dutch
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Project Manager (CPM) Clinical Research Coordinator associate Clinical Project Manager Clinical Supply Coordinator Compliance Manager Study Start-up Specialist Laboratory Technician
  • Work From Home:
    No
  • International:
    Yes

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes