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Summary

global Project Management, fase i-iv experience, 10+ years Clinical research, Quality Assurance manager and gcp Auditor.

extensive experience in (international) Project Management of Clinical trials.

specialty and preference: CNS and rare diseases.

special qualities: Project Management, Coaching, strong Communication and decision making skills

 

i am also a Psychologist and mindfulnesstrainer for teenagers and adults.

Experiences

Current Experience

  • Global Clinical Project Manager (GCPM, GTM) and Quality Assurance Manager

    Tilburg, Netherlands
    Since July 2015

    i am responsible for the Project Management and set-up of a large Phase II-iii international trial in a rare disease.

    tasks: vendor selection and management, Finance, Planning, budgetting, selection of sites etc

    since 2017 i also work as a Quality Assurance manager with the responsibility to set up a qms, implementation and and Training.

    i perform gcp audits

    experience 10+ years in Clinical research, Phase I-iv, monitoring, Project Management, global Project Management.

    I am responsible for the project management and set-up of a large phase II-III international trial in a rare disease.

    Tasks: vendor selection and management, finance, planning, budgetting, selection of sites etc

    Since 2017 I also work as a Quality Assurance Manager with the responsibility to set up a QMS, implementation and and training.

    I perform GCP audits

    Experience 10+ years in clinical research, phase I-IV, monitoring, project management, global project management.

Past Experience

  • Owner & Mindfulnesstrainer Tilburg, Netherlands

    November 2014 --- December 2015

    mindfulnesstraining for young adults and adults.

  • Psychologist Veldhoven, Nederland

    November 2011 --- November 2014

    ·        treating adolescents and adults, e.g. depression, anxiety.

    ·        group work: mindfulness Training (mbct / mbsr) for youth and adults.

    ·        cognitive behavioral therapy and client-centered therapy.

    ·        liaise with other specialists.

  • Psychologist Veldhoven, Nederland

    June 2008 --- October 2011

    ·        psychological assessments, rater qualifications in several questionnaires

    ·        short-term Treatment

    ·        counseling and consultation, triage.

    ·        liaise with other caregivers e.g. gp’s, psychologists, psychiatrists.

  • Country Study Manager Zeist, Nederland

    December 2003 --- May 2008

    country study manager (clinical team Leader), Clinical research, glaxosmithkline, zeist, specialized in Psychiatry and Neurology (CNS).

    ·        managing and Coaching study team (functional Leadership).

    ·        Project Management (responsible for several simultaneous trials phase iia, iib, iiia, iiib, iv)

    ·        working with CRO’s

    ·        liaise and negotiate with gp's and medical specialists, kol’s.

    ·        Training and assigning CRA’s.

    ·        organizing Investigator meetings and Training meetings.

    ·        negotiating with several parties and responsible for study Budgets/contracts.

    ·        financial management

    ·        responsible for study goals and working according to timelines and quality measures.

    ·        developing monitoring plans according to gcp/SOP’s, review monitor reports from CRA’s.

    ·        feasibilities (including site selection).

     ·        international study management on a global level (phase iiib and iv) from 2001 till 2008.

  • Project Manager Clinical Research (CRA) Zeist, Nederland

    December 1998 --- November 2003

    Project Manager Clinical research (CRA), glaxosmithkline, zeist, specialized in Psychiatry and Neurology (CNS).

    ·        setting up and supervising Clinical trials.

    ·        Project Management.

    ·        monitoring.

  • Clinical Research Associate (CRA)

    August 1998 --- December 2000
    setting up and supervising Clinical trials. Project Management. monitoring.

  • Researcher Nijmegen, Nederland

    January 1996 --- November 1998

    Researcher, Psychiatry department radboud Hospital.

    Research topics:

    alcohol addiction

    benzodiazepine dependence

    unipolar depression

    set up Clinical trials and write scientific papers

  • Internship Clinical Psychology

    January 1994 --- January 1995

Personality

Self Assessment :
AdaptabilitySelf-disciplineProblem solvingIndependenceSelf-confidenceAnalytical thinkingAuthenticityCharmCollaborationCoordinationCuriosityEfficiencyInnovative thinkingOptimismProactivityStrivingCommunicativeResponsibilityStrategic thinkingCreative thinkingCritical thinkingKindnessResult OrientedSociabilityTrust

Knowledge

Self Assessment :
Negotiation R&DClinical operationsClinical researchClinical trial budgetingClinical trial managementContract negotiationData AnalysisEthics submission and approval processFamily practiceGeneral practiceGood Clinical Practice (GCP)HospitalsInterpret clinical trial resultsKOL managementManaging Clinical Trial SuppliesPatient Screening and Recruitmentpeople managementPhase IIPhase IIIPhase IVProblem-solving methods and troubleshootingPsychiatryPowerPointProtocolProject ManagementSchizophreniaScreen patientsSOPSupervising CRAsTeam LeadershipPhases of clinical development (phase I to IV)bipolarbipolar disease Quality management Phase IAuditingBudget ManagementBudget NegotiationClinical monitoringCNSComplianceCRODeveloping Clinical Trial ProtocolseCRFICH guidelinesInformed Consent DocumentsInternational Project ManagementNeuroscienceOxidative stressPresentation SkillsProcess improvementQA complianceQuality Assurance (QA)Quality Control (QC)Quality of Life (QoL) outcomesRecruitingStandard Operating Procedure (SOP)TrainingWriting Study Procedures and SOPs
LinkedIn Assessment :
Project ManagementCNS disordersMindfulnessStressClinical researchPsychologyCoachingeerstelijnszorgCognitive TherapyClinical trialsGCPPsychiatryClinical DevelopmentPharmaceutical IndustryClinical monitoringTraining

Skills and Expertise

Self Assessment :
Design case record form (CRF)Design exclusion criteriaDesign inclusion criteriaDesign marketing advertismentsDesign study documentsIndentify sitesInitiation visitManuscript preparation and reviewMonitor a clinical studyMonitor clinical trials Monitor dataMonitoring enrolmentMonitoring subject complianceNegotiate budget Negotiate payment schedulesNegotiationNetworkNew indications of marketed drugOral presentationOrganise meetingsManuscript preparationManage trial master file (TMF)Interact with CROsInteract with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansLiaise with doctorsLiaise with research teamlifescienceManage clinical trial files/documentsManage front deskManage study budgetManage study supplyManage subject consent formOrganise steering committeePatient recruitmentPre-study procedures Review clinical study reportsReview exclusion criteriaReview inclusion criteriaReview monitoring reportsScheduling trial visitsSelect investigatorsSite managementSolve problemsStatistical analysisSupervise clinical monitorsTrain on site staffSupervise trial suppliesVerify dataRetrieve study documentsRespond to audit findingsPlanning clinical studiesPrepare final reportPrepare internal auditsPresent at steering committeePresent clinical resultsPromotional materialsProvide medical insightsProvide study site fileProvide trainingPublication of articlesReport serious adverse events (SAE)Report study conclusionsResearch at universitiesWrite papers Guide studentsbudgeting of R&D activitiesCoachCoach staffCollaborate with principal investigatorCollaborate with project teamCollect patient forms and questionnairesCommunicate with investigatorCollaborate with medical teamConduct close-out visitsComplete study proceduresConduct literature searchesconduct monitor visitsConduct post-marketing surveillance studyAttend steering committeeAttend investigator meeting Interact with physicians Develop protocols Interpret data Monitor a clinical study Report data Search literature on clinical trialsAdverse event reportingApprove monitoring reportsApprove patient informationApprove queriesArchive documentationArchive study documentsAssess site feasibilityConduct research at universitiesConduct site initiationConfirm protocol complianceDevelop study timelinesDirect co-workersDiscuss treatments with investigatorDistribute study documentsDocument adverse eventsDistribute trial suppliesEnsure data integrityEstimate subject complianceEthics committee applicationEthics committee submissionsFollow-up of internal auditsIndentify clinicians to conduct clinical trialsIdentify investigatorsDevelop study budgetDesign subject consent formContract approvalCoordinate ethics committeeCoordinate logisticsCoordinate regular advisory boardCoordinate with the ethics commiteeCreate clinical documentsData verificationData analysis

Education

  • .b trainer mindfulness voor jongeren in Health Care from centrum voor mindfulness in 2014
  • M.Sc in Clinical psychology from Radboud University Nijmegen in 1996
  • Secondary School in Gymnasium alpha from Odulphus lyceum in 1991

Training and Certification

  • Coaching II in 2007 Training
  • Advanced course Team leaders II in 2006 Training
  • Advanced course team Leaders in 2005 Training
  • Communication II in 2005 Training
  • Coaching in 2003 Training
  • Communication in 2002 Training
  • Negotation in 1998 Training
  • GCP Auditing in 2018 Certification
  • Auditing Course in 2017 Certification
  • GCP in 2016 Certification
  • GCP Advanced in 2003 Certification
  • Negotation II in 2003 Certification
  • Project Management in 2003 Certification
  • GCP in 1998 Certification
  • Mindfulnesstrainer young adults in 0000 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Project Leader Clinical Project Manager (CPM) Project Manager Senior Project Manager (PM) Medical Science Liaison (MSL) Trainer Clinical Research Associate (CRA) GCP Auditor
  • Locations I am interested in:
    België Noord-Brabant, Nederland Tilburg, Nederland
  • Work From Home:
    Yes, 2 to 4 days per week
  • Work Regime:
    Permanent position :    75% FTE
    BrightOwl freelancer :    0-28 Hours per week
  • International:
    Yes
  • Availability:
    Jan 2019 : 100%
    Oct 2018 : 50%
    Nov 2018 : 100%
    Dec 2018 : 100%

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Tilburg, Nederland

Others

Driving License
  • Yes

PERSONALITY ASSESSMENT Detail

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