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Experiences

Current Experience

  • Project Manager


    Since July 2014
    • plan, manage and coordinate internal and external Assay development projects in accordance with the company’s application roadmap and in Compliance with qms requirements
    • update senior management and teams on project status
    • keep abreast on scientific literature related to the company’s Biomarkers of interest
    • Plan, manage and coordinate internal and external assay development projects in accordance with the company’s application roadmap and in compliance with QMS requirements
    • Update senior management and teams on project status
    • Keep abreast on scientific literature related to the company’s biomarkers of interest

Past Experience

  • Program Leader

    November 2011 --- July 2014
    • management of internal Biomarker Discovery & Validation programs (in ovarian Cancer, sepsis, pre-eclampsia and Cardiology), fee-for-service projects and international collaborations (eu – fp7 project)
    • initiate and maintain collaborations with clinicians and key opinion leaders

  • International Clinical Study Manager

    November 2007 --- November 2011

    Clinical trial management including e.g.:

    • co-writing of clinical study documents (science)" rel="nofollow">Protocol, icf, monitoring guide, Lab guidelines, …)
    • eCRF development
    • coordination and follow-up of international Clinical trials (including country & site feasibility follow-up, recruitment follow-up, contracts, insurance and budget control)
    • Analysis of study results (including medical review)
    • organisation and participation to internal and external meetings (advisory board, CRO partners)
    • collaboration with different internal and external partners

  • Post-doctoral researcher

    January 2004 --- October 2007

  • Scientific collaborator - immunology/virology unit

    January 2000 --- December 2004
    • ‘hands on’ experience in Medical Research
    • direct collaboration with team members in the Lab

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCoordinationCuriosityCritical thinkingEfficiencyFlexibilityInterest in knowledgeKindnessProactivityProblem solvingSelf-confidenceStrategic thinkingTrustWillingness to compromise

Knowledge

Self Assessment :
Cell biology Labtechnician Negotiation R&D Scientific writingAntibodiesBiomarkersCardiologyCell CultureClinical DevelopmentClinical monitoringClinical operationsClinical Study DesignClinical study reportsClinical trial designClinical trial managementClinical trialsDesigning case report formsEfficacy trialsELISAEnglishEthics submission and approval processIn VitroInfectious diseasesInformed Consent ProcessInterpret clinical trial resultsKOL managementMicrosoft OfficePharmaceutical IndustryPhase IIIPre-clinical researchProject ManagementSOPUnderstand how results translate to practiceUnderstand levels of research evidenceUnderstanding of regulatory guidelinesValidationVirologyWomens HealthVerificationInformed Consent DocumentsWriting Study Procedures and SOPs
LinkedIn Assessment :
Clinical trialsoncologyCROClinical researchBiomarkersLifesciencesBiotechnologyCell CultureCell biologyImmunologyResearchInfectious diseasesscienceIn VitroVirologyMicrobiology

Skills and Expertise

Self Assessment :
Develop clinical trial protocols Develop protocols Interact with physicians Interpret data Monitor a clinical study Write papers Report dataAttend investigator meetingBiomarker Researchbudgeting of R&D activitiesCollaborate with principal investigatorCollaborate with project teamConduct research at universitiesCommunicate with investigatorCommunicate with sponsorcoordinating research projectsCreate study documents

Education

  • PhD in Medical Science from Universiteit Antwerpen in 2004
  • Master in Biomedical Science from Vrije Universiteit Brussel in 1999
  • Bachelor in Pharmaceutical & Biological Techniques from Katholieke Hogeschool 'Sint-Lieven', Gent in 1996

Languages

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

Area / Region

Zwijnaarde, Ghent, Belgium

Others

Driving License
  • Yes

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