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Summary

holding various positions with increasing responsibility throughout the years, i have gained experienced in a multitude of aspects of Clinical research, Regulatory Affairs and scientific communication Strategy. my key competencies : skills : Project Management in Medical Devices area ; scientific communication Strategy ; expertise in regulatory requirements (ce mark Applications) and Clinical trials management ; sensitive to corporate Strategic Planning and business initiatives ; intimate awareness of eu Hospital procedures. knowledge : Medical Devices directives 93/42/eec, 2007/47/ec and new eu Medical Devices regulation (mdr) ; ISO standards ; notified body and competent authorities process, data protection law and gcp. personality : high level professionalism in dealing with clinicians, kols, physicians and regulatory authorities ; ease of multi-tasking ; work to priorities and milestones ; excellent Communication Skills ; team spirit and open mindless.

Experiences

Current Experience

  • Clinical Project Manager_Medical Imaging

    Bordeaux, France
    Since September 2012
    mission 1 (since 2016) : management of a corelab activity in Neurology and Cardiology Clinical trials : 1) Investigator site standardization and certification, site Training, centralization of images, sedt server set up, scientific expertise and results management. 2) tactical management and Leadership to kols and clinicians team. 3) prospection and proposals to academic and industrial customers. mission 2 (since 2012) : promotion of a national program in Medical Research imaging (9m€ of funding, 200 people, 10 research teams, 34 research projects) : 1) development of the attractiveness and the international visibility of the program (visiting scholars program. research results promotion, accelerating Translation with industry). 2)internal and external Communication (website, newsletters). 3) organization of international events. MISSION 1 (since 2016) : Management of a CoreLab activity in neurology and cardiology clinical trials : 1) Investigator site standardization and certification, site training, centralization of images, sEDT server set up, scientific expertise and results management. 2) Tactical management and leadership to KOLs and clinicians team. 3) Prospection and proposals to academic and industrial customers. MISSION 2 (since 2012) : Promotion of a national program in medical research imaging (9M€ of funding, 200 people, 10 research teams, 34 research projects) : 1) Development of the attractiveness and the international visibility of the program (visiting scholars program. research results promotion, accelerating translation with industry). 2)Internal and external communication (website, newsletters). 3) Organization of international events.

Past Experience

  • Clinical Project Manager - CRA Bordeaux, France

    May 2010 --- December 2015

    management of Clinical trials portfolio of neuroimaging department :
    -    institutional and industrial sponsored studies – overall 30 studies,
    -    recruitment of centers : site selection, initiation visit, follow-up and close-out visit,
    -    design of science)" rel="nofollow">Protocol, crf and icf,
    -    regulatory submission,
    -    strict budget management,
    -    sponsor monitoring visit and queries resolution,
    -    patients screening, follow-up visits and eCRF completion.

  • Regulatory & Clinical Affairs Project Manager - Orthopaedic Implants

    May 2005 --- August 2010
    Regulatory Affairs : - writing and submission of ce mark files for class iii implants-overall 100 products (hip, knee, spine), - Negotiation with notified body, - management of Health economic dossiers (Reimbursement) for hip and spine devices, - management of 150 export registrations per year (latin america, china, canada, emea, asia). Clinical trials : - management of pre- and post-marked studies portfolio with R&D and Marketing department : - investigators meeting and sites selection, - science)" rel="nofollow">Protocol and crf design, - management of Clinical research project budget, financial conventions with centers, - regulatory submissions, - report data and results management,

  • Regulatory Affairs Associate

    January 2003 --- January 2005
    • submission of ce mark files for class iii orthopaedic implants, • Medical Device vigilance • export registrations

Personality

Self Assessment :
AdaptabilityCoordinationCollaborationCuriosityDiligenceEfficiencyFlexibilityInterest in knowledgeOptimismOrganizationProactivityResponsibilityResult Oriented

Knowledge

Self Assessment :
CE CertificationClinical DevelopmentClinical operationsClinical monitoringClinical Study DesignClinical study reportsClinical trial designClinical trial managementCMC Regulatory AffairsCommunication SkillsCRF designCROData entryeCRFEntrepreneurshipFDAGood Clinical Practice (GCP)Informed Consent ProcessISO 13485KOL managementMarketing StrategyMedical DevicesMedical ImagingMicrosoft PowerpointMicrosoft WordMicrosoft OfficeMicrosoft ExcelNanotechnologyNeuroscienceoncologyOrthopedicPhase IIIPhase IVProject ManagementProject CoordinationProtocolRegulatory submissionsScientific Communications
LinkedIn Assessment :
Dispositif mEssais cliniquesAffaires rMedical DevicesProject ManagementLeadershipBonnes pratiques cliniquesSciences de la vieClinical researchCE markingClinical trialsClass III Medical DevicesMedical Device DirectiveTeamworkRegulatory affairsStandards ComplianceGCPANSMFDAHealthcare Reimbursement

Skills and Expertise

Self Assessment :
Develop clinical trial protocols Create SOPs Build and manage the Trial Master File (TMF) Develop protocols Design case record forms Monitor a clinical study Write protocolsConduct studiesCoordinate ethics committeeCoordinate projectsCreate clinical project documents according to the protocolData validationData verificationData entryDesign case record form (CRF)Design protocolsManage regulatory activitiesManage multiple projectsManage study budgetNegotiationOrganise meetingsOrganise steering committeePatient recruitmentRegulatory submissionsSet up a clinical studySelect sitesRegulatory documentation

Education

  • Advanced Master in Biomedical Sciences from University of Bordeaux in 2003
  • Post-graduate degree in biomaterials in from Université de Bordeaux in 2002
  • Matser's degree in Physical Chemistry in from Université de Bordeaux in 2001

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Clinical Project Manager (CPM)
  • Locations I am interested in:
    Belgium France
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Bordeaux, France

Others

Driving License
  • Yes

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