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Project Manager in Clinical Trials

Experiences

Current Experience

  • Protocol Manager

    Braine-l'Alleud, Belgium
    Since February 2017
    Biomarker
    • Strong operational understanding of conducting clinical trials.
    • Coordination and contribution to key clinical documents (e.g. Protocols).
    • Establishement and upholding of an effective dialogue with sponsor, investigators, investigative site personnel, Field Medical Science Liaisons, and external vendors.
    • Flexibility and management of studies across organization ( i.e. multiple Therapeutic Areas)
    • Ability to identify potential barriers and mitigation strategies to site start-up
    • Participation in interactions among many different groups including Field Medical Science, Medical Information, Biomarker Team, Global Biostatistics, GCR, and GDO.
    • Process improvement, implementation of departmental standard practices and processes
    • Project management as a whole

Past Experience

  • Laboratory Study Manager

    March 2010 --- January 2017
    Data Management

  • Clinical Trial Assistant (CTA)

    February 2008 --- January 2010
    General Management

  • Laboratory Technician

    August 2004 --- January 2008
    Analysis

Personality

Self Assessment :
AdaptabilityAssertivenessAttention to detailCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityDiligenceEfficiencyFlexibilityInterest in knowledgeOrganizationProblem solvingReaction to stressSelf-confidence

Knowledge

Self Assessment :
Phase I R&D Scientific writing NegotiationBiomedical SciencesBiopharmaceuticalsBiotechnologyBudget ManagementBudget NegotiationCancerCancer ResearchClinical operationsClinical Study DesignClinical study reportsClinical SuppliesClinical researchClinical trialsContract negotiationCRFCTMSData cleaningeCRFEthics submission and approval processGood Clinical Practice (GCP)Good Laboratory Practice (GLP)GXPHematologyHistologyICH guidelinesInformed Consent DocumentsInformed Consent ProcessInternational Project ManagementIVRSLaboratory ResearchLeadershipLifesciencesLogisticsOncology Clinical ResearchoncologyOperations ManagementOutsourcingPatient Follow UpPatient Screening and RecruitmentPharmaceutical ResearchPhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)Project CoordinationProject ManagementProject PlanningProtocolResearchSafety reportingSafety trialsStudy protocols
LinkedIn Assessment :
VaccinesLifesciencesClinical trialsBiochemistryBiotechnologyPharmaceutical IndustryELISAGMPPCRICH-GCPImmunologyGCP

Education

  • Specialist in Herbal Medicine from IFAPME Mons in 2016
  • Bachelor of Science (B.Sc.) in Biomedical Sciences, General from HEMES Saint-Laurent Liège in 2004
  • in Biomedical Sciences, General from FUNDP Namur in 2002
  • in Scientific and Medical Aromatherapy from International College of Aromatherapy in 0000
  • in from International School of Choueifat in 0000

Training and Certification

  • GCLP Training in 2015 Training
  • GCP Training in 2008 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Full Proficiency
    French
    Native

Work Preferences

  • Positions I am interested in:
    Project Manager Clinical Operations Manager Clinical Project Leader Clinical Project Manager (CPM) Global Clinical Project Manager (GCPM, GTM) Project Leader
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
    Belgium Switzerland
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    80-90% FTE
  • International:
    Yes

Area / Region

Lambusart, Belgique

Others

Driving License
  • Yes

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