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Experiences

Current Experience

  • Protocol Manager

    Braine-l'Alleud, Belgium
    Since February 2017
    • strong operational understanding of conducting Clinical trials.
    • coordination and contribution to key clinical documents (e.g. protocols).
    • establishement and upholding of an effective dialogue with sponsor, investigators, investigative site personnel, field medical science liaisons, and external vendors.
    • Flexibility and management of studies across organization ( i.e. multiple Therapeutic Areas)
    • ability to identify potential barriers and Mitigation strategies to site start-up
    • participation in interactions among many different groups including field medical science, medical information, Biomarker team, global Biostatistics, gcr, and gdo.
    • process improvement, implementation of departmental standard practices and processes
    • Project Management as a whole
    • Strong operational understanding of conducting clinical trials.
    • Coordination and contribution to key clinical documents (e.g. Protocols).
    • Establishement and upholding of an effective dialogue with sponsor, investigators, investigative site personnel, Field Medical Science Liaisons, and external vendors.
    • Flexibility and management of studies across organization ( i.e. multiple Therapeutic Areas)
    • Ability to identify potential barriers and mitigation strategies to site start-up
    • Participation in interactions among many different groups including Field Medical Science, Medical Information, Biomarker Team, Global Biostatistics, GCR, and GDO.
    • Process improvement, implementation of departmental standard practices and processes
    • Project management as a whole

Past Experience

  • Laboratory Study Manager

    March 2010 --- January 2017

    •participation in reviewing science)" rel="nofollow">Protocol on an operational Laboratory point of view : contact with the Lab managers to check feasibility of the study regarding workload; check test ids; check type of samples, method of Sampling, material and device to use; decision-taking : use or not of central Laboratory •review of bid proposal to work with central labs •set-up of the study with a central Lab (barc, quest Diagnostics): review of Laboratory worksheet, Lab manual, requisition forms. overview of sample management and shipments. •collaboration with external laboratories for result reporting (cevac, ddl, immunehealth) •follow-up of study set-up internally (all teams have all information available to set up the study in the system; use of SAP) •due dates : review of due dates per study, check if timings fit (article 46!) ; follow-up with the labs, Negotiation with Clinical team and labs if delay foreseen •review of Laboratory listings (histopathology) •interaction with the Data Management to create Laboratory Applications; help in sample reconciliation •monitoring of Lab files (source document Verification, paperwork vs listings)

  • Clinical Trial Assistant (CTA)

    February 2008 --- January 2010
    •participation in reviewing science)" rel="nofollow">Protocol/icf, crf, crf filling guidelines, monitoring guidelines, study leaflet and sops •cta activities: master contact list (preparation, distribution, update), Investigator meeting organization (binders, agenda), Investigator file preparation (ec approval, science)" rel="nofollow">Protocol, agreements, ib, study leaflet), trial master file completion and up-to-date follow up, certification collection, collection of reports (pre-study contact, site evaluation, site initiation, site monitoring), PharmacovigilanceClinical safety acquaintance (sae listings, reconciliation listings/ sae database), imp tracking, sera collection, aliquots preparation and transfer to Lab, General Management of documents (filing, collection, signature qc), qc file (tracking of documents through Excel sheet), archiving •close interaction with cras (drqfs, pdfs, cvs recollection; document tracking) throughout the study

  • Laboratory Technician

    August 2004 --- January 2008
    Training in phlebotomy, hematological Analysis (homeostasis, cytology, Hematology, liquid Analysis), chemical Analysis, immuno-Hematology, basic secretarial knowledge.

Personality

Self Assessment :
AdaptabilityAssertivenessAttention to detailCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityDiligenceEfficiencyFlexibilityInterest in knowledgeOrganizationProblem solvingReaction to stressSelf-confidence

Knowledge

Self Assessment :
Phase I R&D Scientific writing NegotiationBiomedical SciencesBiopharmaceuticalsBiotechnologyBudget ManagementBudget NegotiationCancerCancer ResearchClinical operationsClinical Study DesignClinical study reportsClinical SuppliesClinical researchClinical trialsContract negotiationCRFCTMSData cleaningeCRFEthics submission and approval processGood Clinical Practice (GCP)Good Laboratory Practice (GLP)GXPHematologyHistologyICH guidelinesInformed Consent DocumentsInformed Consent ProcessInternational Project ManagementIVRSLaboratory ResearchLeadershipLifesciencesLogisticsOncology Clinical ResearchoncologyOperations ManagementOutsourcingPatient Follow UpPatient Screening and RecruitmentPharmaceutical ResearchPhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)Project CoordinationProject ManagementProject PlanningProtocolResearchSafety reportingSafety trialsStudy protocols
LinkedIn Assessment :
VaccinesLifesciencesClinical trialsBiochemistryBiotechnologyPharmaceutical IndustryELISAGMPPCRICH-GCPImmunologyGCP

Education

  • Specialist in Herbal Medicine from IFAPME Mons in 2016
  • Bachelor of Science (B.Sc.) in Biomedical Sciences, General from HEMES Saint-Laurent Liège in 2004
  • in Biomedical Sciences, General from FUNDP Namur in 2002
  • in Scientific and Medical Aromatherapy from International College of Aromatherapy in 0000
  • in from International School of Choueifat in 0000

Training and Certification

  • GCLP Training in 2015 Training
  • GCP Training in 2008 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Full Proficiency
    French
    Native

Work Preferences

  • Positions I am interested in:
    Project Manager Clinical Operations Manager Clinical Project Leader Clinical Project Manager (CPM) Global Clinical Project Manager (GCPM, GTM) Project Leader
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
    Belgium Switzerland
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    80-90% FTE
  • International:
    Yes

Area / Region

Lambusart, Belgique

Others

Driving License
  • Yes

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