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Summary

boasting 5 years of experience in Biomedical & pharma industry, my specialities are: -Clinical trials management -Project Management -Medical Imaging -Quality Management: qa/qc/Validation -Software and systems Training and support

Experiences

Current Experience

  • QA Associate II

    Braine-l'Alleud, Belgique
    Since December 2014

    -Biomedical product lifecycle management
    -quality support and guidance for new Product Development
    -quality Risk Management
    -review and approval of test method validations, studies report and science)" rel="nofollow">Protocol
    -change controls systems management

    -Biomedical Product Lifecycle management
    -Quality Support and guidance for New Product Development
    -Quality Risk Management
    -Review and Approval of Test Method Validations, Studies Report and Protocol
    -Change Controls Systems management

Past Experience

Personality

Self Assessment :
Analytical thinkingService orientedSelf-confidenceResiliencyProblem solvingCharmProactivityOptimismInterest in knowledgeEfficiencyCreative thinkingCoordinationCollaborationAttention to detailAdaptabilityApproachability

Knowledge

Self Assessment :
Biostatistics Medical devices Phase IBiopharmaceuticals Biochemistry R&DBiological Drug DevelopmentCAPAClinical DevelopmentFDAClinical trial managementClinical researchClinical Study DesignPhases of clinical development (phase I to IV)Clinical trial budgetingNuclear radiology Good Clinical Practice (GCP)people managementSix SigmapmiProject ManagementRECIST
LinkedIn Assessment :
Medical ImagingCROsciencePeople SkillsMRIMedical DevicesPowerPointMicrosoft ExcelComputer Software TrainingBiotechnologyOperations ManagementComputed TomographyTechnical SupportDigital PhotographyClinical trialsProject ManagementPathologyMicrosoft WordClinical Document WrittingClinical ProtocolsQuality Control (QC)Software ValidationComputed System ValidationComputed RadiographyData ManagementQuality Assurance (QA)Clinical monitoringPharmaceutical IndustryGCPLife SciencesClinical researchISO 13485ISO 14971ICHDispositif mBiotechnologie

Skills and Expertise

Self Assessment :
Report data Interact with physicians Interact with nurses Design case record formsAdjust processes Control dataAssure medical quality Build and manage the Trial Master File (TMF)Coach clinical staffComplete case report form (CRF) Monitor a clinical studyDesign case record form (CRF)Develop ICH/GCP compliant processesInteract with CROsStudy-related documents

Education

  • Master of Science (MS) in Medical Physics from Université René Descartes (Paris V) in 2009
  • Bachelor of Applied Science (B.A.Sc.) in Biothecnology from Université d'Evry-Val d'Essonne in 2007

Training and Certification

  • Certified Associate in Project Management - CAPM in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    10 weeks
  • Positions I am interested in:
    Project Manager Quality manager
  • Locations I am interested in:
    Belgium
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Brussel, Belgique

Others

Driving License
  • No

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