Quality Assurance Manager
Extensive experience in (international) project management of clinical trials.
Specialty: CNS and rare diseases.
Experience in clinical and scientific research (CNS).
Special qualities: project management, coaching, strong communication and decision making skills
I am also a psychologist and mindfulnesstrainer for teenagers and adults.
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 and to implement and train the colleagues.
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.
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.
Set up clinical trials and write scientific papers
Internship Clinical Psychology
January 1994 --- January 1995
AdaptabilitySelf-disciplineProblem solvingIndependenceSelf-confidenceAnalytical thinkingAuthenticityCharmCollaborationCoordinationCuriosityEfficiencyInnovative thinkingOptimismProactivityStrivingCommunicativeResponsibilityStrategic thinking
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
Skills and Expertise
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
.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
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 Certification
Expert has 2 publications (Will be avalible with full profile)