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Summary

Specialties: Clinical Research, GCP, Learning and Development, Training, Learning Management System

Experiences

Current Experience

  • Global Lead LMS Projects and Operations
    Since September 2013
    Responsible for the development and maintenance of system, technology and processes to manage and document staff qualifications, employee training plans and management of learning activities throughout the Global Research & Development organization. Ensure the strategic and operational fit of the Learning Management System (LMS) and set the strategy, direction and resourcing for LMS Administration and support by Functional Service Providers. Drives the vision towards LMS meeting business needs to have an electronic one-stop-shop system for all learning management activities and employee qualification records. Participate in the creation and execution of the LMS-TM mission, objectives and 3-5 year strategic plan. Manage the LMS projects portfolio including appropriate budget and vendors and lead through adequate organizational structures, people management and development.

Past Experience

  • Project Manager Medical Compliance Framework EMEA
    September 2012 --- September 2013
    Lead a global project to set up a framework defining training requirements for regulatory and internal procedures. Implement the Learning Management System in order to assign training and track compliance in the most efficient way, and have consistency across the countries.

  • European Clinical Education and Learning Manager
    September 2008 --- October 2012
    Lead and co-ordinate training activities for Clinical and Medical staff, performance improvement projects and ensure consistency across the region.

  • Training Officer
    January 2001 --- September 2008
    Responsible for setting up induction and training programs for Medical department staff; training needs analysis; Learning Management System; interaction with external service providers and CROs.

  • Clinical Research Associate (CRA)
    January 1999 --- January 2001
    Responsible for delivery of clinical studies including budgets (cardiovascular, respiratory) and coaching of monitors.

  • Clinical Trial Manager / Clinical Supplies Coordinator
    January 1990 --- January 1999
    Responsible for delivery of clinical studies including budget (oncology, respiratory, cardiovascular, antibiotics, anesthesiology, migraine) ; line-management of monitors; storage and distribution of study drugs.

  • Clinical Research Associate (CRA)
    January 1987 --- January 1990
    Responsible for monitoring of Clinical Studies (oncology, antibiotics, anesthesiology).

  • Medical Department Officer
    January 1985 --- January 1987
    Responsible for answering scientific /customer queries and collating data for regulatory files.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAssertivenessAttention to detailAuthenticityCollaborationCommunicativeCoordinationCritical thinkingDiligenceEfficiencyFlexibilityIndependenceInterest in knowledgeOptimismProactivityProblem solvingResult OrientedSelf-confidenceSelf-disciplineService orientedStrategic thinkingTrustWillingness to compromise

Knowledge

Self Assessment :
Phase I R&D21 CFR Part 11Adverse Events (AE)AnesthesiaBacteriologyBudget ManagementBudget NegotiationCAPACancerCardiologyChange ManagementClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical SuppliesClinical trial audits and inspectionsClinical trial managementCoachingComplianceCross-functional team leadershipDeveloping Clinical Trial ProtocolsDrug development processEnglishEthics submission and approval processInformed Consent ProcessInternational Project ManagementmanagementMicrosoft OfficeOperations Managementpeople managementPharmacistsPhase IPhase IIPhase IIIPhase IVProject ManagementRoot Cause Analysis (RCA)Serious Adverse Event (SAE)Standard Operating Procedure (SOP)Supervising CRAsStudy outcomes and outcome measuresTeachingTeam BuildingTeam LeadershipTrainingUrologyValidation
LinkedIn Assessment :
Clinical DevelopmentGCPProject ManagementLearning Management SystemsVirtual TeamsComplianceInternational NetworkingPharmaceutical IndustryEmployee TrainingTrainingSOPICH-GCPDrug DevelopmentCROClinical Study DesignCTMSTherapeutic AreasEDCClinical Data ManagementMedical affairsPharmacovigilanceMedicineRegulatory submissionsCardiologyClinical pharmacologyDiabetesMedical writingLearning ManagementClinical researchClinical trialsTraining & DevelopmentPharmaceuticals

Skills and Expertise

Self Assessment :
Analytical skills Create SOPs Design case record forms Develop clinical trial protocols Guide students Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdjust processes Administer, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingApprove consent documentsApprove drug supply Approve Label Master SheetApprove monitoring reportsApprove patient informationApprove suitability of patient information and consent documentsAssess site feasibilityassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist study siteAttend at steering committee meetingsAttend investigator meetingAttend seminars, courses and meetings within and outside the companybudgeting of R&D activitiesCoach and provide guidance to clinical staff.collaborate in research projects at universitiesCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with project teamCollect patient forms and questionnairesCommunicate effectively on different company levelsCommunicate with investigatorConduct close-out visitsConduct maintenance visitsConduct post-marketing surveillance studyConduct site initiationCoordinate projectsCreate clinical project documents according to the protocolCreate SOPsDevelop ICH/GCP compliant processesDevelop training materialsDocument employees training requirementsEnsure good clinical practice (GCP)Follow up training programsFollow-up of internal auditsIdentify and provide training to trial team and associated staffIdentify investigatorsImplement ProcessesLead teamsLead studiesManage risksPeople managementPlan work to meet objectives and deadlinesProvide trainingRead medical literature to maintain current awareness and knowledgeReport serious adverse events (SAE)Supervise clinical monitorsWork cross-functionally

Education

  • Apotheker in Pharmacy from Universiteit Leiden in 1985
  • vwo in from Huygens Lyceum, Voorburg in 1977

Languages

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

Work Preferences

  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80-100% FTE
  • International:
    No

Area / Region

Netherlands

Others

Driving License
  • No