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Summary

Six Sigma yellow belt. Clinical trials specialist. experienced project Coordinator for the Pharmaceutical Industry. in-depth knowledge of ich-gcp, GMP, glp. strong background in Immunology, Virology, molecular biology and Biochemistry.

Experiences

Current Experience

  • Clinical Trials Expert & QC Engineer

    Mechelen, Belgium
    Since February 2018

    Consultant in intermission.

    Coaching junior & medior Life Sciences consultants in Clinical operations, ich-gcp, glp, GMP, 21cfr, Auditing, analytical tests Validation and qc, Medical Devices (iso13485)

    Consultant in intermission.

    Coaching Junior & Medior Life Sciences consultants in Clinical Operations, ICH-GCP, GLP, GMP, 21CFR, Auditing, Analytical Tests Validation and QC, Medical Devices (ISO13485)

Past Experience

  • Technical & Scientific Affairs Specialist

    January 2015 --- October 2017
    - review of the client's clinical protocols, extraction of the clinical tests required and assessment of their in-house feasability. - during Clinical Trial budget preparation, help budget analysts and contract negociation group to cover all costs linked to Lab Testing. approval of Lab Testing part of the budget.

  • Lab Study Manager for GSK Biologicals

    May 2011 --- December 2014
    • ensure effective interface between R&D Testing laboratories and Clinical project team, by providing input in study science)" rel="nofollow">Protocol, Laboratory instructions for Investigator sites, informing about Testing due dates, sample management or Testing issues. • at study level, pro-actively coordinate studies set-up & follow-up of operational Laboratory related activities

  • External Labs & Project Coordinator for GSK Biologicals

    October 2009 --- May 2011
    operational coordination of external Lab partners performing Biological Assays for gsk.

  • Head of Biological Testing Lab

    November 2001 --- March 2004
    management of a team of 8 Lab technicians in a glp Lab. Quality Control of raw materials and drugs according to european and us pharmacopoeia. plan Assays according to business priorities. fields covered: Bacteriology, sterility Testing, physical Testing, Biological Assays.

  • Junior Technical Project Manager

    June 1996 --- January 2001
    Animal models against viral diseases (hbv & hcv). development & Validation of qPCR and rt-PCR Assays for hbv 1 hcv detection and quantitation. pre-Clinical and first-to-human assessment of pilot anti-viral drugs.

  • Research associate

    January 1990 --- October 1995
    technical assistance to post-doctorate students. fields covered: Bacteriology, molecular biology, Virology, Cell Culture.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAssertivenessApproachabilityCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityEfficiencyFlexibilityInnovative thinkingInterest in knowledgeKindnessOptimismOrganizationPerspectiveProactivityProblem solvingResiliencyResponsibilityResult OrientedSelf-confidenceSelf-disciplineTrustAuthenticityDiligenceSociabilityWillingness to compromise

Knowledge

LinkedIn Assessment :
Clinical trialsImmunologyRT-PCRELISAValidationmolecular biologyCell CultureoncologyTechnology transferVirologyProject CoordinationAuditingBacteriologyPCRTest developmentTest ValidationGMPGood Laboratory Practice (GLP)ICH-GCPLean Six SigmaOncologieTransfert technologiqueCulture de cellulesBiologie moléculaireEssais cliniquesImmunologieVirologieRéaction en chaîne par polyméraseFunctional AssaysStudy set-up with central labssample management & logisticsLab & clinical bridgingsSecteur pharmaceutiqueSciences de la vieBiotechnologieRecherche cliniqueBonnes pratiques cliniquesGDPR

Skills and Expertise

Self Assessment :
Analytical skills Assure medical quality Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Interact with nurses Interact with physicians Interpret data Molecular Diagnostics Monitor a clinical study Search literature on clinical trials Technology research Use content management systems Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust methodsAdjust processes Administer logisticsAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingAdvise on strategyAnalyze data/information to determine potential relationships.Analyze proteinAseptic techniquesAssess business and scientific ethicsAssess product quality issuesAssess quality process issuesAssess site feasibilityAssess subject safetyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist study siteAssist with experimentsAssist with proceduresAssist with routine testsAssist with site trainingAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyAttend steering committeeBiomarker Researchbudgeting of R&D activitiesCell cultureCoach and provide guidance to clinical staff.collaborate in research projects at universitiesCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct literature searchesConduct maintenance visitsConduct research at universitiesConduct site initiationConduct supply issue resolution activitiesConfirm protocol compliancecoordinating research projectsCoordinationCreate SOPsCreates a collaborative team environmentData entryDesign clinical presentationDesign scientific experimentsDesign scientific projects (in biology)Develop strong internal relationships with stakeholdersDirect co-workers to achieve resultEstablish professional relationships with partnersEvaluate physico-chemical dataEvaluate physico-chemical data of lab scale/pilot scale batchesExecute scientific projectsFacilitate sponsor monitoring visitsFollow up projectsFollow-up of external auditsFollow-up of internal auditsHandle incidentsIdentify and provide training to trial team and associated staffInteract with nursesInteract with physiciansInteract with pre-clinical scientistsInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific dataLead teamsLiaise with doctorsLiaise with professionals in other divisions of the company as requiredLiaise with research teamLiaise with research team in order to accurately collect and record dataManage Clinical Trial Management System (CTMS) Manage clinical suppliesManage contractors Manage laboratory proceduresManage multiple projectsManage research projectsManage risksmanaging a small teamObserve trends in dataOptimize assay performanceOperate research equipmentOral presentationOrganise meetingsOrganize scientific projects (in biology)pcrPeople managementPerform routine testsPlan experimentsPlan work to meet objectives and deadlinesPrepare external auditsPrepare internal auditsPrepare investigator brochuresPresent at steering committeePresent data at congressProcure and prepare samplesproject managementProvide support for scientific and/or technical projectsProvide technical supportProvide trainingPublication of articlesQuality control processR&DRead medical literatureReport technical problemsReview data interpretationReview protocolsReview quality control activitiesReview the interpretation of dataSearch literature on clinical trialsSelect contractors Set up research projectsSetup of research equipmentShipment of biological specimenSupervise analysts and researchersSupervise techniciansSupervise trial suppliesTeach university studentsTrain off site staffTrain on site staffTranslate protocol into packaging and labeling requirementsTranslate strategy into operational plansUse laboratory techniquesUse western blotting techniqueVerify dataWork collaboratively with the other members of the clinical research team Work cross-functionallyWork with coordination and data management teamsWrite documentsWritten presentation

Education

  • in Validation/Qualification/Protocol Writing/Tests execution. GMP & GLP Compliance Training. from CEFOCHIM in 2017
  • Master in Molecular Biology & Biotechnologies. in Biotech/Molecular Biology from Université libre de Bruxelles in 1989
  • Biochemical Engineer in Biotechnologies/Biochemistry from Institut Meurice - Haute Ecole Lucia De Brouckère. in 1987

Training and Certification

  • CRA Training in 2009 Training
  • Six Sigma Yellow Belt in 2018 Certification
  • Fire Marshal in 0000 Certification
  • Red Cross Medic in 0000 Certification
  • Six Sigma Yellow Belt in 0000 Certification

Languages

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

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Associate Scientist associate Clinical Project Manager Biologist Clinical Project Manager (CPM) Clinical Research Consultant Clinical Research Coordinator Clinical Research Manager Clinical Supply Manager Clinical Trial Coordinator (CTC) CMC Project Manager Lab Scientist Laboratory Engineer Laboratory Manager Molecular Biologist Preclinical Research Manager Preclinical Scientist Project Manager R&D engineer R&D Scientist Research associate Scientific Researcher Senior Associate Scientist
  • Positions I am NOT interested in:
    Bioinformatician BioStatistician Clinical Data Reviewer Data Manager Marketing Manager Procurement Expert Purchase Medicins Sales Manager
  • Locations I am interested in:
    Belgium
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    No

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

PERSONALITY ASSESSMENT Detail

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