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Summary

OBJECTIVE 

  •           Exercise professional activities in Clinical Operations as people manager.

  •        Working with a team. Supported by my experience, coaching, motivating people to reach their goals and ensure achievement of personal and team/company targets.

 And/or

  •          Exploring new areas “Pharma & Non-Pharma”, new challenges which are in line with my interests, personal competence and professional expertise.

 

 

Experiences

Past Experience

  • CRM Anderlecht, België
    January 2010 --- April 2015

    Pharma

    • Clinical Research Unit Management CRM (Clinical Research Manager)
      Astellas --> 5 year

    • Clinical Research Project Management CRA (Clinical Research Associate)
      Astellas/Yamanouchi/Ciba-Geigy --> 18 years
    • Medical Sales Representative
      Ciba-Geigy --> 5 years

    Non-Pharma

    • Scientific research 
      HIVA KU Leuven --> 1 year
    • Physical Therapist
      Replacement --> 2 years

     

Personality

Self Assessment :
AdaptabilityWillingness to compromiseTrustStrategic thinkingService orientedSelf-disciplineSelf-confidenceOrganizationApproachabilityInnovative thinkingProblem solvingIndependenceAnalytical thinkingCollaborationCoordinationCreative thinkingAuthenticityCritical thinkingFlexibilityOptimismProactivityInterest in knowledge

Knowledge

Self Assessment :
General practiceCAPACancerCardiovascular diseasesCardiologyActions and modes of action of human physiologyA rising single dose tolerance study Scientific writing R&DClinical Data Management (CDM)Clinical DevelopmentClinical monitoringContract negotiationClinical trialsClinical trial managementClinical trial designClinical trial budgetingClinical trial audits and inspectionsClinical study reportsClinical Study DesignClinical researchClinical pharmacologyAllergy and immunologyClinical operations Phase I NegotiationPediatricsSOPSerious Adverse Event (SAE)Screen patientsStrategic PlanningSupervising CRAsVerificationTeam LeadershipUnderstand how results translate to practiceUnderstanding of regulatory guidelinesUrologyInformed Consent DocumentsSafety trialsSafety concerns (such as therapeutic ratio with respect to possible adverse effects)PowerPointProblem-solving methods and troubleshootingProcess improvementProtocolPsychiatryQuality Assurance (QA)Quality of Life (QoL) outcomesR&DRandomization and blindingRandomization SystemsRheumatologyWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Interact with physicians Monitor a clinical study Report data Search literature on clinical trialsAdjust processes and methodsApprove consent documentsTrain on site staffTrain off site staffSupervise clinical monitorsSolve problemsSite managementSelect investigatorsSet up a clinical studyWritten presentationApprove monitoring reports Design case record formsAdjust methodsAdjust processes Conduct monitor visitsCollaborate with medical teamCollaborate with principal investigator Control dataCoachCoach staffCoach clinical staffApprove patient informationArchive study documentsAssess site feasibilityAssign activitiesAttend investigator meetingbudgeting of R&D activitiesCommunicate with investigatorCommunicate with sponsorSupervise techniciansStudy-related documentsReview study protocolsReview quality policiesReview quality control activitiesReview queriesReview monitoring reportsReview inclusion criteriaReview exclusion criteriaReview clinical study reportsRespond to audit findingsVerify data Assure medical qualityArchive documentationAssist study siteAssist with proceduresAssure medical qualityCollaborate with project teamCollect financial data from hospitalsConduct close-out visitsConduct post-marketing surveillance studyConduct site initiationConduct the trialCalculate trial timelinescoordinating research projectsCreate clinical documentsCreate study documentsDesign case record form (CRF)Document employees training requirements

Education

  • Master in Physical Education and Fysiotherapy from KUL in 1983
  • High Secondary School in Degree Latin- Greek from Sancta-Maria Anwerpen in 1978

Training and Certification

  • • Convincing Presentation Workshop in 2013 Training
  • • INSIGHTS Discovery in 2013 Training
  • Regulatory Inspection and Customer Audit in 2013 Training
  • • Advanced Interview in 2011 Training
  • • Patient Recruitment & Retention in 2011 Training
  • • Management: “Leiden en Begeleiden” in 2010 Training
  • • Time Management in 1997 Training
  • Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Research Manager Clinical Research Associate (CRA) Clinical Project Leader Clinical Research Consultant Clinical Project Manager (CPM) BrightOwl Admin Clinical Operations Manager Clinical Research Associate (CRA) Project Manager Project Coordinator Senior Clinical Research Associate (CRA)
  • Locations I am interested in:
    België
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    FTE: 60-80 % FTE
    BrightOwl employee :    FTE: 60-80 % FTE
  • International:
    Yes

Area / Region

Antwerpen, België

Others

Driving License
  • Yes