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Summary

Freelancer supporting clinical research activities and innovative projects with expertise and Flexibility, locally and through europe. Clinical Research Consultant providing services as regulatory submissions, CRA, Project Manager, Auditor or Interim Manager on a Freelance basis. home-based in belgium but open to extensive travel internationally.

Experiences

Current Experience

  • Freelance Clinical Research Consultant

    Hoepertingen, Belgium
    Since March 2009

    march 2009 - currently                         

    Clinical Research Consultant for several sponsors

    (see cv for extensive experience Freelance activities)

    med-i-mart bvba (own company) and Partner triq

     

    january 2007- march 2009

    manager Clinical Research Associates emeac                

    st jude medical european hq

    da vincilaan 11 – box f1 1935 zaventem, belgium

     

    march – december 2006                      

    senior CRA - emeac                                                                     

    st jude medical european hq

    da vincilaan 11 – box f1 1935 zaventem, belgium

     

    february 2005 – march 2006              

    Quality Assurance specialist – Associate

    guidant european hq                                                                       

    culliganlaan 2b 1831 diegem, belgium

     

    october 2001- february 2005             

    CRA cardiac rhythm management

    guidant european hq                                                                    

    culliganlaan 2b 1831 diegem, belgium

     

    april 2000 - october 2001                     

    Project Manager for the dimetra-s project

    motorola, european hq

    excelsiorlaan 89 in b- 1930 zaventem, belgium

     

    before 2000                                               

    positions in distribution and Logistics.

    March 2009 - Currently                         

    Clinical Research Consultant for several sponsors

    (see CV for extensive experience freelance activities)

    Med-I-Mart BVBA (own company) and Partner TRIQ

     

    January 2007- March 2009

    Manager Clinical Research Associates EMEAC                

    St Jude Medical European HQ

    Da Vincilaan 11 – Box F1 1935 Zaventem, Belgium

     

    March – December 2006                      

    Senior CRA - EMEAC                                                                     

    St Jude Medical European HQ

    Da Vincilaan 11 – Box F1 1935 Zaventem, Belgium

     

    February 2005 – March 2006              

    Quality Assurance Specialist – Associate

    Guidant European HQ                                                                       

    Culliganlaan 2B 1831 Diegem, Belgium

     

    October 2001- February 2005             

    CRA Cardiac Rhythm Management

    Guidant European HQ                                                                    

    Culliganlaan 2B 1831 Diegem, Belgium

     

    April 2000 - October 2001                     

    Project Manager for the Dimetra-S project

    Motorola, European HQ

    Excelsiorlaan 89 in B- 1930 Zaventem, Belgium

     

    Before 2000                                               

    Positions in distribution and logistics.

Personality

Self Assessment :
Analytical thinkingAssertivenessApproachabilityCharmCollaborationCommunicativeAttention to detailCompetitivenessCritical thinkingDiligenceEfficiencyFlexibilityIndependenceInnovative thinkingInterest in knowledgeOrganizationPerspectiveProactivityProblem solvingResponsibilityResult OrientedService orientedStrategic thinkingTrust

Knowledge

Self Assessment :
Negotiation Phase I21 CFR Part 11Adverse Events (AE)Allergy and immunologyAuditingBacteriologyBiomarkersBudget ManagementBudget NegotiationBudget ProcessBudgetingBudgetsBusiness IntelligenceBusiness PlanningBusiness ProcessBusiness Process ImprovementBusiness ProcessesCancerCancer ResearchCAPACardiologyCardiovascular diseasesCDISCCE CertificationCell CulturecGMPChange ControlChange ManagementClinical Data ManagementClinical Data Management (CDM)Clinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical trial audits and inspectionsClinical trial budgetingClinical SuppliesClinical trial designClinical trial managementClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsCoachingColorectal surgeryComplianceCompliance with regulationsContinuous ImprovementContract negotiationCRFCRF designCross-functional team leadershipCTMSCustomer ServiceData ManagementDatabasesDermatologyDiagnosticsDrug AccountabilityDrug DeliveryDue DiligenceeCRFEDCEfficacy trialsElectrocardiogram (ECG)Electronic Data Capture (EDC) ElectrophysiologyEMAEndocrinologyEndocrinology and metabolismEnglishEntrepreneurshipEpidemiologyEthics submission and approval processFDAGastroenterologyGeriatric medicineGermanGood Clinical Practice (GCP)Good Laboratory Practice (GLP)GynecologyHealth EconomicsHealthcare industryHealthcare ReimbursementHematologyHospitalsICH guidelinesImmunologyInfectious diseasesInformed Consent DocumentsInformed Consent ProcessInnovation ManagementInternational Project ManagementInterventional CardiologyInterventional RadiologyInventory ManagementISOISO 9001IVRSIt skillsKOL managementLaboratoryLaboratory ManagementLeadershipLife SciencesLogisticsQuality AssuranceQuality ManagementQuality of Life (QoL) outcomesQuality Control (QC)Quality Management System (QMS)Regulatory RequirementsScreen patientsSocial SkillsStudy approvalsVascular surgerySleep Apneacolorectal cancerValvesCardiovascular interventionStentsChronic Pain Management

Skills and Expertise

Self Assessment :
Analytical skills Create SOPs Design case record forms Develop clinical trial protocols Interact with nurses Interact with physicians Interpret data Monitor a clinical study Report data Technology research Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdjust processes and methodsAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingApprove monitoring reportsArchive trial documentation and correspondence.Assemble regulatory applicationsAssess subject safetyAssist study siteAttend at steering committee meetingsAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyBuild trial master file (TMF)Calculate timelines for conducting and completing the trialCoachCoach clinical staffCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationControl studiesCoordinate logisticsCoordinate projectsCoordinate with the ethics commiteeCreate clinical documentsCreate clinical project documents according to the protocolCreate SOPsCreate standard operating procedure (SOP)Create study documentsCreates a collaborative team environmentData verificationDesign case record form (CRF)Conduct studiesConfirm protocol complianceContract approvalcontrol different protocol versions and other essential documentsControl protocol versionsDevelop ICH/GCP compliant processesDevelop study timelinesDevelop training materialsDirect co-workersDistribute study documentsDistribute trial suppliesEnsure data consistencyEnsure good clinical practice (GCP)Establish contractsEstablish professional relationships with partnersEstablish relationships with Key Opinion LeadersEthics committee submissionsEvaluate protocolsExecute internal/external quality assurance assessmentsFacilitate sponsor monitoring visitsFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesIdentify investigatorsIdentify risksIdentify sites

Languages

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

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Research Associate (CRA) Freelance Project Manager Auditor
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    BrightOwl freelancer :    32 Hours per week :    80 Free Per Month(in coming months)
  • International:
    Yes

Area / Region

Hoepertingen, Belgium

Others

Driving License
  • Yes

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