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Experiences

Current Experience

  • Regulatory Affairs Manage Wavre, Belgium
    Since May 2014

    Driving specific process or procedural document developments and updates within Regulatory Affairs with Standard Operation Procedure or Work Instruction owners as stakeholders. Dissecting of various processes and ways of working applied within Regulatory Affairs and assessing the most logical and effective ways in order to meet business and compliance needs.

    Therapeutic Area/Lab Experience

    • Vaccines

    Key areas of Responsibility

    • Ensure that processes being developed/re-engineered are adequately, appropriate and robust processes and that these processes (and/or associated procedural documents) clearly reflect the roles and responsibilities of the various groups within RA
    • Manage and facilitate input from Subject Matter Experts into the generation of written procedures and processes
    • Developing Key Performance Indicators to assess the efficiency of the new processes/interfaces

  • Regulatory Process Manager
    Since May 2014

Past Experience

  • Director Clinical Research Anderlecht, Belgium
    May 2012 --- May 2014

    Overall responsible for clinical trials operations and regulatory affairs

    Assist in technical file preparation.

    Therapeutic Area/Lab Experience

    • Oncology – Device First‑in‑Man (similar to Phase I in Pharma)

    Key areas of Responsibility

    • Writing and updating of cross divisional product development standard operation procedures
    • Continuing with on-going programs with high financial restraints
    • Set up of department budget based on agreed goals and time lines and evaluate frequently based on actual expense

  • Director Clinical Research
    June 2012 --- May 2014
    Responsible for clinical studies, including site contact, CRO management, budget tracking, time lines and regulatory affairs within the team of MDW.

  • Clinical Research Coordinator
    May 2009 --- June 2012
    Coordinating a Phase 1 type study

  • Clinical Study Planning Manager
    May 2006 --- October 2008
    Clinical Study Planning Manager (May 2006 – October 2008) Senior Clinical Operations Manager (April 2002 – May 2006)

  • Clinical Research Associate (CRA)
    January 1994 --- January 2002
    INVERESK RESEARCH Ltd (previously ClinTrials Research) December 1994 – March 2002 - Belgium: • Principal Clinical Research Associate (July 1999 – March 2002) - Belgium: • Senior CRA (February 1997 – July 1999) + project management team world wide - Chile: CRA – Trainer for South America staff (May 1996 – February 1997) - Global Europe: CRA based in Belgium (December 1994 – May 1996): Monitoring international studies

  • Assisting Academic Personal
    July 1992 --- December 1994
    Fundamental research in the parasite Echinococcus granulosus involving laboratory, field work and local staff education in Chile.

Personality

Self Assessment :
Analytical thinkingApproachabilityAssertivenessAttention to detailCommunicativeCollaborationCoordinationDependabilityDiligenceEfficiencyFlexibilityIndependenceInterest in knowledgeOrganizationProactivityProblem solvingResponsibilityResult OrientedSelf-disciplineService orientedSociabilityStrategic thinking

Knowledge

Self Assessment :
BiotechnologieBudget ManagementBusiness Process ImprovementCAPACancerCardiologyChange ControlCommunication SkillsCompliance with regulationsContinuous ImprovementContract negotiationCRF designCROCross-functional team leadershipDeveloping Clinical Trial ProtocolsElectronic Data Capture (EDC) EnglishEnzyme-linked immunosorbent assay (ELISA)Ethics submission and approval processFDAForecastingGCPGood Manufacturing Practice (GMP)Healthcare industryHospitalsICH GCP guidelinesInformed Consent ProcessInternational Project ManagementInternational RelationsInterventional RadiologyLeadershipmanagementManaging Clinical Trial SuppliesMedical DevicesMicrosoft OfficeMicrosoft ProjectMitigationMolecular & Cellular BiologyMultilingualOperating RoomOperations ManagementOutsourcingPatient recruitmentPatient Screening and Recruitmentpeople managementPharmaceutical IndustryPharmacokineticsPharmacovigilancePhases of clinical development (phase I to IV)Presentation SkillsProblem SolvingProcess improvementProgram ManagementQA complianceRegulatory affairsReport WritingRoot Cause Analysis (RCA)Search literature on clinical trialsTeam LeadershipTime ManagementTrainingVaccinesWriting Study Procedures and SOPs
LinkedIn Assessment :
CTMSCROGCPClinical trialsPharmaceutical IndustryRegulatory affairsClinical Development

Skills and Expertise

Self Assessment :
Create SOPs Develop clinical trial protocols Search literature on clinical trialsAdverse event reportingApprove suitability of patient information and consent documentsAssess product quality issuesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Collaborate with medical teamCommunicationControl studiesCreate SOPsCreate study documentsDevelop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials Implement Key Performance Indicators (KPI's)Liaise with doctors and other professionals throughout the studyMaintain Quality Management System (QMS)Manage risksNegotiationOrganise steering committeePeople managementProvide trainingResearch at universitiesSolve problemsWork cross-functionally

Education

  • Master in Zoological Sciences from RUG in 1991
  • Master in Biology from Ghent University in 1991

Training and Certification

  • External Personal in Operating Room with badge as Technical Advisor in 2012 Certification

Languages

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

Work Preferences

  • Notice Period:
    13 weeks
  • Positions I am interested in:
    Associate Director Clinical Operations Associate Director Regulatory Affairs & Pharmacovigilance Benelux Clinical Operations Manager Clinical Project Manager (CPM) Global Clinical Project Manager (GCPM, GTM) Managing Director Operations Project Leader Project Manager Quality Assurance (QA) Manager Regulatory Affairs Manager Regulatory Affairs Officer Senior Project Manager (PM) Senior Regulatory Affairs Manager
  • Locations I am interested in:
  • Work From Home:
    Yes, 2 to 3 days per week
  • International:
    Yes

Area / Region

Oud-Heverlee, Belgium

Others

Driving License
  • No