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Summary

Aiming for excellence in your projects!

Experiences

Current Experience

  • International Project Manager Clinical Research
    Since May 2014

Past Experience

  • Clinical Monitor (clinical project manager)
    April 2010 --- May 2014
    Managing clinical research projects on a local and regional (Benelux) level in the field of oncology, respiratory and CNS. Involved in the local and regional change and implementation of company's SOP's. Involved in the development and implementation of quality improvement projects in clinical research. Involved in the development of clinical project plan for local clinical project managers.

  • Clinical Research associate via Valesta
    June 2008 --- March 2010
    Monitoring of clinical trials on a local level in the field of oncology, respiratory and CNS.

  • Clinical Manager Europe via Valesta
    January 2007 --- January 2008
    Management of sales and marketing activities of medical devices at a European level. Implementation of first in-human trial of medical devices in Germany.

  • European Trainer Interventional Systems
    January 2007 --- June 2007
    Training of European Sales Team in the cardio-vascular medical device portfolio of Terumo Europe.

  • Nurse Specialist Adult Congenital Cardiology
    December 2003 --- December 2006

  • Intensive care nurse
    July 2000 --- December 2006

Personality

Self Assessment :
ApproachabilityAttention to detailCoordinationCreative thinkingDependabilityEfficiencyInnovative thinkingOrganizationProblem solving

Knowledge

LinkedIn Assessment :
oncologyCardiologyHospitalsNeurologySOPInfectious DiseasesPharmacovigilanceDiabetesCTMSICH-GCPGCPClinical monitoringTherapeutic AreasElectronic Data Capture (EDC)

Skills and Expertise

Self Assessment :
Assure medical quality Build and manage the Trial Master File (TMF) Control data Create SOPs Develop clinical trial protocols Guide students Interact with nurses Interact with physicians Monitor a clinical study Report data Search literature on clinical trials Use content management systems Write papersAdjust processes and methodsApprove consent documentsApprove drug supply Approve Label Master SheetApprove monitoring reportsApprove patient informationApprove queriesArchive documentationArchive study documentsAssess site feasibilityCoachCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamConduct monitor visitsConduct literature searchesConduct site initiationConduct the trialConduct university research Confirm protocol complianceContract approvalCoordinate regular advisory boardCoordinate with the ethics commiteecoordinating research projectsCreate clinical documentsCreate SOPsCreate study documentsData verificationDesign information leafletDevelop study budgetDevelop study metricsDevelop study timelinesDirect co-workersEnsure good clinical practice (GCP)Ethics committee applicationEthics committee submissionsEvaluate protocolsFinancial administrationFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGeneral office managementHandle callsInteract with CROsInitiation visitManage study budgetManage study supplyManage subject consent formManage trial master file (TMF)Negotiate budget Negotiate payment schedulesNegotiate protocol details Patient recruitmentPreparing referral lettersPresent clinical resultsPresent data at congressProvide medical insightsProvide trainingRead medical literatureRegulatory documentationRegulatory submissionsReview vendor reportsSelect contractors Set up a clinical studySite managementStudy execution planSupervise clinical monitors

Education

  • Post-graduate degree in from Katholieke Universiteit Leuven in 2008
  • Master in from Katholieke Universiteit Leuven in 2006
  • Bachelor in from Katholieke Hogeschool Leuven in 2001
  • Bachelor's degree - RN in from Katholieke Hogeschool Leuven in 2000

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Professional Proficiency
German
Professional Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Work From Home:
    Yes, 1 to 2 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Hever

Others

Driving License
  • Yes