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Experiences

Current Experience

  • Clinical Data Coordinator and Quality System Coordinator Antwerp, Belgium
    Since April 2016

    As a clinical data coordinator, I am responsible for creating studies in the Electronic Data Capturing system, and to create sample Case Report Forms.

    I also follow up on issues that are detected in the system.

    As Quality System Coordinator, I am responsible for the creation and timely review of quality documents in the company's document quality system.

Past Experience

  • Clinical Research Coordinator Antwerp, Belgium
    December 2013 --- April 2016

    As a Clinical Research Coordinator, it was my responsibility to organize the conduct of studies at the Clinical Pharmacology Unit: I ordered the necessary materials, wrote manuals, attended dosings, made sure staff planning was ok,...

Personality

Self Assessment :
AdaptabilityApproachabilityAssertivenessAttention to detailCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityDependabilityEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOptimismOrganizationProactivityProblem solvingResiliencyResponsibilityResult OrientedSelf-confidenceSelf-disciplineService orientedSociabilityTrustWillingness to compromise

Knowledge

Self Assessment :
Phase IBudget ManagementCAPAClinical operationsClinical trial managementClinical trialsComplianceCRFCRF designData cleaningData entryData ManagementeCRFEDCEnglishGood Clinical Practice (GCP)ICH guidelinesInformed Consent ProcessLeadershipLife SciencesMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordOutlookPhase IPhases of clinical development (phase I to IV)Presentation SkillsPrinciples and ethics of clinical researchProblem SolvingProject CoordinationProject ManagementProtocolQuality AssuranceQuality Control (QC)Quality Management System (QMS)RecruitingRoot Cause Analysis (RCA)Standard Operating Procedure (SOP)Writing Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Analytical skills Control data Create SOPs Design case record forms Interact with nurses Interact with physiciansAdjust processes and methodsAdministrative supportArchive study documentsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend investigator meetingCapture data on source documentsClinical data collectionCommunicate with investigatorCommunicate with sponsorCommunicate effectively on different company levelsComplete case report form (CRF)Coordinate projectsCoordinationCreate SOPsDevelop ICH/GCP compliant processesEnsure consistency between the protocol and CRFFacilitate sponsor monitoring visitsInteract with nursesInteract with pharmacistsInteract with physiciansLead teamsManage data collection systemPeople managementproject managementProvide trainingReview protocolsSchedule trial visitsSet up a clinical studyTrain StaffUnderstand protocols

Education

  • Bachelor in Archaeology from KU Leuven in 2009

Languages

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

Work Preferences

  • Notice Period:
    6 weeks
  • Locations I am interested in:
    Antwerp, Belgium Boom, Belgium Brussels, Belgium Heist-op-den-Berg, Belgium Kontich, Belgium Mechelen, Belgium Puurs, Belgium
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    No

Area / Region

Mechelen, Belgium

Others

Driving License
  • Yes