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Summary

Key roles at currect job:

  • Product development (medical devices, cosmetics, biocides, pharmaceuticals) with main focus on insects (e.g. ectoparasites) and fungal infections (hair, nail, skin)
  • Formulation development
  • Regulatory affairs support (implementation design and development procedures, data collection, clinical evaluation, reporting, document management, building technical file...)
  • Clinical studies (set-up, follow-up, statistics, reporting...)
  • Scientific writing
  • Scientific support of the QC/QA and marketing department
  • General project management
  • Networking (building and improving connections with existing and new CROs)

Specialties (based on current and previous job experiences):

  • OTC product development
  • Product design and development
  • Regulatory affairs
  • Clinical trials
  • ART culture media Stem cell culture media
  • Development of new freezing media for gametes/mammalian cells
  • Diagnostics (development and optimization)
  • Quality control tools
  • Validation according to ICH, CLSI, and other guidelines


Scientific Skills:

  • Analytical techniques: chromatography (HPLC, FPLC…), titration, spectrophotometry …
  • Biosafety
  • Cell culture (mammalian cells, yeast, embryo culture, sperm cells)
  • Clinical evaluation of medical devices / risk analysis
  • Colloid chemistry
  • Culture media and buffers (development, optimization) for ART and stem cell culture
  • Diagnostics (development, optimization)
  • Enzymology (enzyme assays, kinetics)
  • Genomics (plasmid production and purification, PCR, real time PCR, electrophoresis…)
  • Immunology (ELISA, Western blotting, bead coating …)
  • Medical devices
  • Microbiological techniques
  • Protein techniques (purification, quantification, influence of medium composition on protein stability)
  • Purification / filtration techniques (dialysis, cross flow…)
  • Recombinant protein expression (fermentation, mammalian cells, plasmid production and purification, transfection techniques)
  • Sterility (aseptic working, clean room, endotoxin removal and detection…)
  • Stability studies

Experiences

Current Experience

  • R&D Project Manager Drongen
    Since January 2016
    Product & formulation development (OTC, medical devices, pharmaceuticals) - (Ectoparasites - Fungal infections)
    Regulatory support
    Clinical studies
    Scientific support of the QC/QA, production, and marketing department.
    Project management
    Networking
    Communication with external parties (notified bodies, commercial companies, CROs...)

  • R&D manager
    Since September 2008
    Cfr. summary

Past Experience

  • Officina pharmacist
    January 2007 --- January 2008
    “Flying” pharmacist at different pharmacies of the COOP group

  • Hospital Pharmacist (maternity leave replacement)
    April 2007 --- November 2007
    Supervision of the hospital pharmacy Medication supply Accountancy

  • Hospital Pharmacist (maternity leave replacement
    January 2006 --- January 2007
    Supervision of the hospital pharmacy Medication supply Accountancy

  • PhD student
    January 2000 --- December 2006
    Effects of (xeno)estrogens on male fertility Effect of estrogens on hypothalamo-pituitary-gonadal axis PhD Thesis: "Estrogenic effects in the gonadotropic LBetaT2 and AlphaT3-1 cell lines"

Personality

BrightOwl Assessment :
PerspectiveCuriosityInterest in knowledgeAdaptabilityKindnessCharmDiligenceOrganizationDependabilityAttention to detailEfficiencyApproachabilityAssertivenessReaction to stressSelf-discipline
Self Assessment :
Self-confidenceAssertivenessOptimismSelf-disciplineAttention to detailSociabilityIndependenceApproachabilityInterest in knowledgeAdaptabilityWillingness to compromise

Knowledge

BrightOwl Assessment :
Understand levels of research evidenceUnderstand how results translate to practiceScientific methodologyUnderstanding of regulatory guidelinesData entryProject ManagementWriting Study Procedures and SOPs
Self Assessment :
Understanding of regulatory guidelinesScientific methodologyWriting Study Procedures and SOPsProject ManagementInformed Consent ProcessData entryUnderstand how results translate to practiceInterpret systematic reviewsDrug development processUnderstand levels of research evidenceEndocrinology and metabolismClinical Data ManagementClinical Data Management (CDM)Clinical researchClinical Study DesignClinical study reportsClinical trial designClinical trial managementClinical trialsDeveloping Clinical Trial ProtocolsGood Clinical Practice (GCP)Good Clinical Practice Veterinary (GCPv)Clinical Trial Management System (CTMS)Pre-clinical researchPreclinical ResearchPrinciples and ethics of clinical researchSearch literature on clinical trialsClinical Lab scale batches Negotiation R&D21 CFR Part 11Adverse Events (AE)Allergy and immunologyAnalysisAnalytical ChemistryAnalytical Method ValidationAnalytical methodsAnalytical proceduresAnalytical techniquesAntibodiesApplicationsAseptic ProcessingAseptic TechniquesAssay developmentBudget ManagementCell Based AssaysCE CertificationChange ControlChromatographyCleanroomCleaning ValidationChemistry, Manufacturing, and Controls (CMC)CoachingCross-functional team leadershipData AnalysisData ManagementData cleaningDesign VerificationDesigning case report formsDNADNA extractionICH guidelinesHealthcare industryGood Publication Practice (GPP)grant writing and designEndocrinologyEnzyme-linked immunosorbent assay (ELISA)Failure Mode and Effect Analysis (FMEA)FDAGood Laboratory Practice (GLP)Good Manufacturing Practice (GMP)Instrument Validation ProtocolsLaboratory study designLiquid Chromatography-UV (LC-UV)Medical Device R&DMedical DevicesMedical writingMicrosoft WordPharmaceutical IndustryProduct designProduct developmentProduct EngineeringProduct launchProduct managementProject CoordinationSDS-PAGESafety concerns (such as therapeutic ratio with respect to possible adverse effects)Serious Adverse Event (SAE)Standard Operating Procedure (SOP)Statistical Data AnalysisStudy approvalsStudy outcomes and outcome measuresStudy proposalsStudy protocolsTeam BuildingTeam LeadershipValidation
LinkedIn Assessment :
Enzyme KineticsEnzyme ActivityHPLCFiltrationAseptic TechniquesTitrationSpectrophotometryMammalian Cell CultureYeastMedical Device R&DColloidsMedical Diagnosticsreal-time PCRPCRWestern BlottingBeadsrecombinant DNA technologyTransient TransfectionProtein-protein InteractionsRisk AnalysisSOP developmentValidationStability StudiesAccelerated Life TestingStem CellsCell CultureQuantitative PCR (qPCR)GenomicsMicrosoft OfficeWordExcelPowerPointMedcalcDigimizerStatistical SoftwareEnzyme-linked immunosorbent assay (ELISA)Assisted ReproductionProtein chemistryProtein ExpressionEnzyme Assays

Skills and Expertise

BrightOwl Assessment :
R&D Write protocolsWork with coordination and data management teamsWork under specific instructions to assist with routine tests, experiments, and proceduresWork collaboratively with the other members of the clinical research team Support special projects requiring QA input.assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Coach and provide guidance to clinical staff.Create clinical project documents according to the protocolConduct limited data and/or statistical analysis.Direct co-workers to achieve resultDevelop protocolsimplement quality control process throughout the conduct of the trialInterpret dataObtain grants for clinical researchObserve and report trends in data/information.
Self Assessment :
Write protocolsBiomarker ResearchR&DlifescienceAssemble regulatory applicationsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Conduct research at universitiesConduct limited data and/or statistical analysis.Conduct literature searches.Create Standard Operating Procedures for each study or clinical trial.Attend seminars, courses and meetings within and outside the companyAttend at steering committee meetingsDetermine availability of facilities and equipment at the siteAnalyze data/information to determine potential relationships.Answer, transfer and handle incoming calls as needed.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collect data as required by the protocol and complete case report forms and reviews for completeness.control different protocol versions and other essential documentsDesign the studyDevelop protocolsDirect co-workers to achieve resultEdit dataEscalate compliance and study issues to Director, Study ManagementEnsure that all meetings arranged run smoothly by producing agenda, including timetable, minutes and action pointsInteract with computer specialistsInterpret dataLiaise with research team in order to accurately collect and record dataObtain grants for clinical researchperform data entryPerform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.Prepare sound articles for publicationperform Data validationperform Data verificationRead medical literature to maintain current awareness and knowledgeReview the interpretation of data Molecular DiagnosticsWrite combined statistical and medical reportsSupport special projects requiring QA input. Analytical skills Analyze data Assure medical quality Create SOPs Control data Design case record forms Develop clinical trial protocols Develop protocols Guide students Interact with physicians Interpret data Lab scale batches Report data Search literature on clinical trials Technology research Use a confocal microscopy Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust methodsAdjust processes Adjust processes and methodsAdverse event reportingApprove suitability of patient information and consent documentsAseptic processingAseptic techniquesAssess adverse reactionsAssess quality process issuesAssess site feasibilityAssess subject safetyAssign activitiesAssist study siteAssist with experimentsAssist with proceduresAssist with routine testsAssist with site trainingAssure medical qualityAttend investigator meetingAttend seminarsAttend steering committeebudgeting of R&D activitiesCell cultureClinical data collectionCoachCoach and provide guidance to clinical staff.Coach staffcollaborate in research projects at universitiesCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCollect dataCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationComplete case report form (CRF)Complete study proceduresConduct literature searchesConduct post-marketing surveillance studyConduct studiesConduct the trialConduct university research Confirm protocol complianceControl protocol versionsControl studiesCoordinate projectsCreate clinical documentsCreate clinical project documents according to the protocolCreate SOPsCreate standard operating procedure (SOP)Create study documentsCreates a collaborative team environmentData entryData miningData validationData verificationDesign case record form (CRF)Design clinical presentationDesign clinical trialDesign exclusion criteriaDesign inclusion criteriaDesign database Design liquid productsDesign information leafletDesign post-marketing surveillance studyDesign protocolDesign protocolsDesign scientific experimentsDesign scientific projects (in biology)Design studiesDesign trial master file (TMF)Determine statistical analysis Determine needsDevelop clinical hypothesesDevelop clinical strategyDevelop extraction methodsDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesDevelop study budgetDevelop training materialsDirect co-workersDiscuss treatments with investigatorDistribute study documentsDistribute trial suppliesDocument data collection systemDocument employees training requirementsdrafting grant applicationsEnsure consistency between the protocol and CRFEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Establish contractsEstablish professional relationships with partnersEstablish relationships with Key Opinion LeadersEvaluate impurity identificationEvaluate licensing opportunitiesEvaluate physico-chemical dataEvaluate physico-chemical data of lab scale/pilot scale batchesEvaluate post-marketing surveillance studyEvaluate protocolsEvaluate stability data Evaluate stability data and impurity identification/synthesisExecute scientific projectsExtrapolate dataFacilitate sponsor monitoring visitsFeasibility analysis of proposed trial designFollow up projectsFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesGeneral office managementGenerate regulatory submissions Guide staffGuide studentsHandle callsHandle incidentsIdentify and provide training to trial team and associated staffIdentify growth / improvement potentialIdentify risksImplement data collection systemImplement data reporting systemsInformed consent processInteract with CROsInteract with ethics committeeInteract with pharmacistsInteract with physiciansInteract with statisticiansInterpret analytical resultsInterpret research resultsInterpret scientific dataMaintain strong relationshipsMaintenance of biomedical equipmentManage aseptic riskManage clinical trial files/documentsManage complexityManage contractors Manage Clinical Trial Management System (CTMS) Manage data collection systemManage data reporting systemsManage laboratory proceduresManage multiple projectsManage projects resourcesManage regulatory activitiesManage research projectsmanaging a small teamManufacture of non-GMP batchesManuscript preparationManuscript preparation and reviewManuscript reviewMonitor dataNegotiate protocol details NegotiationNetworkNon-aseptic processingObtain grantsObserve trends in dataOffice managementOperate research equipmentOptimize assay performanceOral presentationOrganise meetingsOrganise steering committeeOrganize scientific projects (in biology)Oversee data collectionParticipate in medical reviewpcrPeople managementPerform routine testsPersuade clinicians to conduct clinical trialsPilot scale batchesPlan experimentsPlan work to meet objectives and deadlinesPlanning clinical studiesPrepare external auditsPrepare final reportPrepare internal auditsPrepare investigator brochuresPrepare manuscriptPrepare regulatory documentsPreparing referral lettersPresent at steering committeePresent clinical resultsPresent data at congressProcure and prepare samplesproject managementProtocol managementProvide medical insightsProvide support for scientific and/or technical projectsProvide technical supportProvide trainingPublication of articlesPublish scientific projectsQuality control processRead medical literatureReferral lettersRegulatory documentationRegulatory submissionsReport non-compliance incidentsReport Key Performance Indicators (KPI's)Report serious adverse events (SAE)Report study conclusionsReport technical problemsResearch at universitiesResolves queriesReview clinical study reportsReview data interpretationRespond to audit findingsRetrieve study documentsReview exclusion criteriaReview inclusion criteriaReview informed consent processReview manufacturing documentationReview medical reportsReview monitoring reportsReview protocolsReview quality control activitiesReview quality policiesReview queriesReview study protocolsSchedule trial visitsSearch literature on clinical trialsSet up research projectsSetup of research equipmentShipment of biological specimenSerious Adverse Event (SAE) ReconciliationSite managementSolve problemsSpecimen processingStatistical analysisStudy execution planSubmit regulatory applicationsSupervise data processingSupervise PhD studentsSupervise techniciansTeach university studentsTrain off site staffTrain on site staffTrain StaffTranslate clinical research concepts into specific objectivesStorytellingStudy-related documentsUnderstand protocolsUse laboratory techniquesUse western blotting techniqueValidate dataVerify dataWork collaboratively with the other members of the clinical research team Work cross-functionallyWork under specific instructionsWork with coordination and data management teamsWrite clinical evaluation reportsWrite combined statistical and medical reportsWrite documentsWrite final reportsWrite medical reportsWrite papersWrite statistical reportsWriting regulatory documentsWritten presentationwrite and maintain clinical evaluation reports

Education

  • Pharmacist in from Universiteit Gent in 1999
  • College in from Mater Amabilis in 1994

Training and Certification

  • IPMA Project Management in 2010 Training
  • Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    40 Hours per week
    BrightOwl employee
  • International:
    No

Publications

    Expert has 16 publications (Will be avalible with full profile)

Area / Region

Beernem

Others

Driving License
  • Yes