An all round Manager Clinical Operations with a proven track record in Clinical Research in the Pharmaceutical industry and Clinical Reserach Organisations. Over 20 years of experience in working according to ICH-GCP, EU Clinical Trials Directive, Code of Federal Regulations of the FDA and associated laws and regulations. Able to work on own initiative and as part of a team. My experience includes managing, developing and driving Clinical Research strategy in Clinical Operations in the Netherlands and Nordics, specialized in Regulatory and Start-Up. I have excellent leadership, communication and organizational skills. Training, development and coaching of people is my passion. Known to be creative, innovative and out-of-the-box thinking.
Manager Clinical Operations
Since November 2015
Associate Director Regulatory & Start-Up (Clinical Operations) Netherlands & Nordics
January 2013 --- September 2015
Main roles are management of the Regulatory & Start-Up teams in the Netherlands, Denmark, Finland & Sweden (including start-up in Norway and Icekand from those countries) and member of the Western Europe & Africa RSU Management Team. As of January 2015: Global Subject Matter Expert Role on Translations. Responsibilities include: - Oversight of all Regulatory and Start-Up responsibilities in the Netherlands, Denmark, Finland, Iceland, Norway and Sweden. - Line management and coaching of the line managers within RSU in those countries. Team of 30 people, 4 line managers. - Member of the Western Europe & Africa RSU Management team. - Special focus on cross-border delivery in my country mix. - SME Translations: global responsibility for centralized translations process. Issue escalation and resolution, mediation between end user and the 2 contracted Global Translation Vendors.
Associate Director Clinical Operations - Site Start-Up
April 2009 --- December 2012
Main roles were member of the strategic management of the Clinical Operations department and Manager of the Dutch site start-up (SSU) team. Responsibilities include: - Management and coaching of the Dutch SSU team. Team of 15 people. - Line management of part of the SSU team as well as of a Manager ClinOps – SSU (who is responsible of the rest of the SSU team). - Represent NLD SSU within the Western European Integrated Site Services team. - Member of the European SSU Management team. - Resources management and liaison with Clinical Teams and project management. - Strategy for Clinical Operations. - Special focus on development and coordination of training for the department Clinical Operations. - Member of the Global Line Managers Support office.
Associate Director - CTL Manager
September 2007 --- March 2009
Main roles were member of the strategic management of the Clinical Operations department and line manager of Clinical Team Leads (CTL) and Clinical Trial Assistants (CTA) supporting CTLs (15 people). Responsibilities include: - Management, line-management and coaching of global and regional CTLs. - Management, line-management and coaching of CTAs supporting international CTLs. - Resources management and liaison with Clinical Teams and project management. - Strategy for Clinical Operations. - Special focus on development and coordination of training for CTLs and CTAs.
Operations Manager Infrastructure
July 2005 --- August 2007
Main roles were 1) member of the strategic management of Infrastructure & Operations. This central service department was integrated with and supporting the Clinical Research department as well as supporting Regulatory Affairs, Pharmacovigilance and Therapeutic Area in BIO R&D Europe. 2) Line management and 3) content expert on Safety Information related processes and Records management. Responsibilities included: - Safety information; content expert and process owner. - Records Management; Records Management coordinator for BIO R&D Europe and content expert. - Management, line-management and coaching of the Infrastructure Support Group; group consisting of secretaries, and CTAs; responsible for the administrative and logistic support of the Clinical Trials Management department. - Process improvement in general.
Operations Manager, Training & Process Development
December 2002 --- June 2005
Main role was managing and developing training strategies, activities and processes and coordination of general process development both in close cooperation with and supporting the Clinical Research department. Responsibilities included: - Development and training of procedural documents. - Facilitate and give training on Clinical Research related topics (e.g. GCP, legislation etc.). - Provide support with issues regarding GCP and legislation with regard to clinical research (ICH-GCP, EU-CTD, SOPs etc.). - As trainer being responsible for the implementation by training of the Clinical Trial Directive in BIO R&D Europe. - Process improvement in general.
Clinical Research Associate (CRA)
August 1996 --- November 2002
- Phase II and III clinical studies (Infectious Diseases, Cardiovascular, Psychiatry, Rheumatology, and Oncology): Project management and partly site management with monitoring. - Development of a filing system in house and at the investigational sites for all clinical studies. - Development and training of Standard Operating Procedures. - Internal expert on legislation with regard to clinical research (GCP, WMO, CCMO). - Application management of Clinical Trial Management software System (IMPACT); system administration, internal helpdesk, training.
Trial Center Manager
October 1995 --- July 1996
Phase II and III clinical studies (Infectious diseases): Study management and site management with monitoring.
January 1995 --- September 1995
- Phase IV clinical studies (Psychiatry, Infectious diseases): Project management. - Medical Marketing tasks for antidepressant product.
Clinical Trial Monitor
March 1993 --- December 1994
- Phase IV clinical studies (Psychiatry, Dermatology): Monitoring and site management. - Development of a filing system for Phase IV trials. - System administrator of software applications for the department.
November 1992 --- February 1993
Clinical study; the effect of magnesium supplementation in women with mild hypertension: Analyze the results and write the study report.
Research scientist (Epidemiology)
February 1992 --- October 1992
Erasmus Rotterdam Gezondheid en Ouderen study: Analyze the relation between the IMT of the carotis and haemostatic factors.
Analytical thinkingApproachabilityCollaborationCreative thinkingFlexibilityProactivityProblem solvingSelf-disciplineResponsibilityStrategic thinkingTrust
Negotiation Phase I R&D21 CFR Part 11Adverse Events (AE)Budget ManagementBudget ProcessBudgetsBusiness DevelopmentBusiness Process ImprovementBusiness ProcessesCAPACE CertificationChange ManagementClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical SuppliesClinical trial audits and inspectionsClinical trial budgetingClinical trial designClinical trial managementClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsCoachingCommunication SkillsCompliance with regulationsContinuous ImprovementContract negotiationCRFCROCross-functional team leadershipCTMSCustomer ServiceDrug AccountabilityDrug DevelopmentDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug safety assessmentDue DiligenceeCTDEDCEMAEmergency medicineEnglishEpidemiologyEthics submission and approval processEvent ManagementFDAGood Clinical Practice (GCP)GXPHuman ResourcesICH guidelinesIMPDINDInformed Consent DocumentsInformed Consent ProcessISOIVRSKnowledge of the drug development processKOL managementLeadershipmanagementMedical budget managementMedical DevicesMitigationMonitoring Study ProgressNegotiationOperations ManagementOutsourcingPatient recruitmentPatient Screening and Recruitmentpeople managementPharmaceutical IndustryPharmaceutical managementPharmaceutical ResearchPhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)Presentation SkillsPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingProcess improvementProtocolQA complianceQuality Control (QC)Quality Management System (QMS)Randomization and blindingRecruitingRisk ManagementSafety reportingSafety trialsSerious Adverse Event (SAE)Social SkillsStandard Operating Procedure (SOP)StrategyStudy approvalsStudy outcomes and outcome measuresStudy protocolsSupervising CRAsTeam BuildingTeam ManagementTeam LeadershipTeamworkTime ManagementTrainingTranslationUnderstand how results translate to practiceUnderstanding of regulatory guidelinesValidationVerificationWriting Study Procedures and SOPs
Skills and Expertise
Analytical skills Analyze data Create SOPs Guide students Interact with nurses Interact with physicians Monitor a clinical study Report data Search literature on clinical trials Use content management systemsAct 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 monitoring reportsApprove patient informationArchive study documentsAssess business and scientific ethicsAssess quality process issuesAssess subject safetyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend investigator meetingAttend seminars, courses and meetings within and outside the companybudgeting of R&D activitiesBuild trial master file (TMF)CoachCoach clinical staffCoach staffCommunicate effectively on different company levelsCommunicationContract approvalCoordinate ethics committeeCoordinate logisticsCreate clinical documentsCreate SOPsCreate standard operating procedure (SOP)Create study documentsCreates a collaborative team environmentDesign clinical presentationDetermine needsDevelop clinical strategyDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesDevelop strong internal relationships with stakeholdersDevelop training materialsDirect co-workers to achieve resultDocument employees training requirementsEnsure good clinical practice (GCP)Follow up training programsFollow-up of Quality Management System (QMS) processesIdentify and provide training to trial team and associated staffIdentify growth / improvement potentialImplement ProcessesImplement Quality Management System (QMS)Lead teamsLiaise with professionals in other divisions of the company as requiredMaintain clinical evaluation reportsMaintain Quality Management System (QMS)Maintain strong relationshipsManage budgetsManage Clinical Trial Management System (CTMS) Manage complexityManage contractors managing a small teamNegotiate budget NetworkObserve trends in dataPeople managementPlan work to meet objectives and deadlinesPlanning clinical studiesPrepare external auditsPrepare internal auditsProvide input to process improvement initiativesProvide trainingQuality control processRead medical literature to maintain current awareness and knowledgeReport Key Performance Indicators (KPI's)Review monitoring reportsReview quality control activitiesReview quality policiesSet-up quality policiesSolve problemsSupervise clinical monitorsTrain StaffTranslate strategy into operational plansWork cross-functionally
Master of Science (MSc) in Health Science - Biological Health Science from Universiteit Maastricht in 1993
High School in from Pallas College, Zoetermeer in 1987