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Summary

experienced Clinical research Director. dutch national/eu citizenship, with keen sense of multi-cultural business etiquette and practice. team-builder, pragmatic, strong Analytical Skills and natural Leadership skills. specialties: Operations, management, process optimisation, Quality Systems, Project Management, Clinical Trial Operations, different Therapeutic Areas incl. oncology, Business Development, international Drug Development (Phase I-iv), international Clinical research.

Experiences

Current Experience

  • Site Relationships and Operations Lead - Europe


    Since March 2014

Past Experience

  • Director Embedded Clinical Operations (Strategic Partnerships) - EMEA

    September 2009 --- March 2014

  • Director Clinical Operations (Study Start Up Western Europe)

    May 2007 --- June 2009

  • Manager Clinical Operations / country manager

    January 2001 --- January 2007

  • Manager Quality Assurance/International Auditor

    January 2000 --- February 2002

  • Head Project Management

    July 1999 --- January 2000

  • Clinical Trial Manager (CTM)

    June 1996 --- July 1999

  • Clinical Research Associate (CRA)

    June 1995 --- June 1996

  • PhD student

    September 1990 --- June 1995

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCompetitivenessCritical thinkingIndependenceProblem solvingResult OrientedSelf-disciplineStrategic thinkingWillingness to compromise

Knowledge

LinkedIn Assessment :
Business DevelopmentClinical trialsTeam ManagementmanagementTeam LeadershipProcess OptimizationGCPQuality SystemCritical Chain Project ManagementLean Six SigmaCROInfectious diseasesPharmaceutical IndustryDrug DevelopmentClinical researchICH-GCPCTMSTherapeutic AreasClinical monitoringClinical DevelopmentoncologyRegulatory submissionsPharmacovigilanceVaccinesClinical Data ManagementEDCRegulatory affairsMedical writingMedical affairsSOPProtocolClinical Study DesignNeurologyDiabetesCardiologyHematologyEndocrinologyClinical operationsBiotechnologyImmunologyRheumatologyFDALifesciencesChange Management

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Create SOPs Interact with physicians Monitor a clinical studyAct as the main line of communication between the sponsor and the investigatorAnalyse growth / improvement potentialAssess quality process issuesAssess business and scientific ethicsbudgeting of R&D activitiesCoach and provide guidance to clinical staff.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Communicate with sponsorCommunicate with investigatorConduct the trialCoordinate projectsDevelop ICH/GCP compliant processesEstablish relationships with Key Opinion LeadersEthics committee submissionsFollow-up of quality assurance activitiesGenerate regulatory submissions Identify and provide training to trial team and associated staffManage complexityManage research projectsManage vendor budgetsNegotiationPeople managementPresent data at congressSet up a clinical studySupervise clinical monitorsUpdate Clinical Trials Management System (CTMS)

Education

  • PhD in Medicine from Radboud University Nijmegen in 1990
  • Atheneum B in from RSG Schoonoord in 0000

Training and Certification

  • PhD in Medicine in 1995 Certification

Languages

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

Work Preferences

  • Notice Period:
    9 weeks
  • Positions I am interested in:
    Clinical Director Europe Clinical Operations Manager Clinical Project Leader Global Clinical Project Manager (GCPM, GTM) Manager Medical Director QC/QA Manager Quality Assurance (QA) Manager Quality manager R&D Director Study director
  • Locations I am interested in:
  • Work From Home:
    Yes, 1 to 2 days per week
  • Work Regime:
    Permanent position :    80-100% FTE
  • International:
    Yes

Area / Region

Zeewolde, Netherlands

Others

Driving License
  • Yes

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