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Experiences

Current Experience

  • Compliance Oversight Lead
    Since April 2015
    The Pfizer Compliance Oversight Lead (COL) role at the department of Site Management & Compliance- Global Clinical Trial Execution is designed to provide oversight of Pfizer clinical trials to assess the overall safety of both the patient and the trial. The COL partners with the site, CRA and the study team to ensure the study is conducted in accordance with the protocol, prevailing laws, ICH GCP and Pfizer standards at the Country level. Oversight activities will include on site visits plus regular reviews of monitoring related activities, study data, protocol compliance and overall study health.

Past Experience

  • Expert Clinical Research Associate/ Local Trial Manager
    January 2015 --- March 2015

  • Clinical Project Manager (CPM)
    October 2012 --- December 2014
    Managing and supervising of clinical research projects. Leadership in the delivery of services to clients, review of work by the project team. Takes role in day-to day- management of full service studies, ensuring that project are delivered on time and according to client expectations.

  • Senior Clinical Research Associate/ Head of Office
    December 2011 --- December 2014
    Responsible for all projects running in the Netherlands and Belgium. Ensuring compliance with protocol, GCP, regulations and procedures. Managing IEC and CA submissions in both the NL and BE; managing clinical (co-) monitoring activities, the selection of investigator/sites, initiating and monitoring of sites. As a Benelux HoO responsible for organizing and coordinating office operations and procedures in order to ensure organizational effectiveness and efficiency; Managing CRAs in accordance with organization’s policies and applicable regulations. Conduct onboarding training for new staff in Benelux and France office

  • Clinical Research Associate (CRA)
    September 2008 --- December 2011

  • Clinical Trial Monitor
    November 2007 --- August 2008

  • Clinical Research Associate (CRA)
    August 2007 --- August 2008

  • Sales and Service Coordinator/ Nutritionist/ Yoga Teacher/ Allround Fitness Instructor
    January 2005 --- July 2007

  • Clinical Trial Internship
    January 2001 --- January 2002

Personality

Self Assessment :
Attention to detailFlexibilityResult OrientedCoordinationCommunicativeCollaborationDiligenceProactivityProblem solvingResponsibilityResiliencyWillingness to compromise

Knowledge

Self Assessment :
BiopharmaceuticalsVaccinesUnderstanding of regulatory guidelinesUnderstand levels of research evidenceTeamworkTeam ManagementSupervising CRAsStudy protocolsStudy outcomes and outcome measuresStudy approvalsSports medicineSerious Adverse Event (SAE)Safety reportingRoot Cause Analysis (RCA)FDAEthics submission and approval processEvent ManagementElectronic Data Capture (EDC) Early development stagePharmaceutical IndustryPharmaceutical ResearchPharmaceutical DevelopmentAdverse Events (AE)Allergy and immunologyCAPACardiovascular diseasesClinical monitoringClinical trial audits and inspectionsClinical Trial Management System (CTMS)ComplianceCROICH guidelinesInformed Consent ProcessGood Clinical Practice (GCP)QA complianceQuality Assurance (QA)Clinical operationsClinical researchClinical trialsStandard Operating Procedure (SOP)
LinkedIn Assessment :
Clinical trialsGCPoncologyClinical researchICH-GCPCROEDCInfectious diseasesClinical DevelopmentPharmaceuticalsNeurologyCTMSInformClinical monitoringHematologyCardiologyRegulatory submissionsVaccinesPharmaceutical IndustryBiotechnology IndustryOncology Clinical ResearchProject ManagementYoga

Skills and Expertise

Self Assessment :
Report non-compliance incidentsConfirm protocol complianceMonitoring subject complianceAssess quality process issuesQuality control processIdentify risksAdjust processes and methodsOrganise meetingsDevelop ICH/GCP compliant processesEnsure good clinical practice (GCP)Train Staff Monitor a clinical studyReview monitoring reportsReview protocolsReview informed consent processWork collaboratively with the other members of the clinical research team Manage clinical trial files/documentsManage multiple projectsProtocol managementSite management

Education

  • in from Clinical Research Development Program at Quintiles in 2007
  • in from CRAcademy in 2006
  • in Nutrition and Health Sciences from Wageningen Universiteit en Researchcentrum in 2005
  • in Human Movement Studies from The University of Queensland in 2004
  • in Exercise Physiology from Utrecht University in 2003

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Dutch
Native

Work Preferences

  • Positions I am interested in:
    Compliance Manager Quality Assurance (QA) Manager Quality manager QC/QA Manager QA Lead Clinical Operations Manager Clinical Development Consultant Clinical Trial Specialist (CTS) Clinical Project Manager (CPM) Clinical Research Consultant Clinical Research Manager CRA Manager Quality Lead
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
    Belgium Netherlands
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    0.8-0.9-1.0% FTE
  • International:
    Yes

Area / Region

Hendrik-Ido-Ambacht, Netherlands

Others

Driving License
  • Yes