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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 Protocol
    -Change Controls Systems management

Past Experience

  • Project Manager
    February 2012 --- April 2014
    Clinical trial management: site management, KPI reporting, study timelines and budget management, Study Set-up: Provide Critical Analysis on site study feasibility, clinical staff training, Study centers Monitoring and queries management, CRA and Study Center staff training on clinical protocol, Clinica Study Supplies Management, e-CRF design and validation, Coordinationof Quality Assurance & Quality Control of clinical data, Central Readers management: selection, training and technical support, Imaging Operations Management: data processing, database administration, software training & support, Study document redaction: Manuals, Charters, Note to File, Data Management plan coordination, SOP review, External and Internal Audit preparation, CAPA Management.

  • Medical Imaging Specialist
    April 2010 --- January 2012
    Quality Assurance of medical Imaging Data. Data Processing of Imaging Clinical Data, Central readers Technical support, Assist Imaging Scientific Manager in clinical study documents and SOP redaction.

  • Assistant Production Coordinator
    February 2009 --- July 2009
    Product Management: Technetium 99m. Production SOP review and update Quality Control SOP review. Quality Assurance SOP review.

  • Assitant Medical Physicist
    January 2008 --- March 2008
    - Dosimetry Calculation for Oncology photon/electron beam treatments, - Quality Control of Linear Accelerator - Quality Assurance of Linear Accelerator

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 médicalBiotechnologie

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 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