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Summary

Biomedical Engineer with experience in Clinical research conduct, currently looking for opportunities in Medical Device industry.

Experiences

Current Experience

  • Clinical Research Specialist


    Since March 2015

    coordination of multi-center european pilot trial for innovative neuromodulation Medical Device for the Treatment of heart failure

    • field support to sites (france, belgium, norway & serbia) for :

    - site staff Training (investigators, study coordinators)

    - field Technical Support in the or for implantations

    - field Technical Support at patient follow-ups

    • perform monitoring & co-monitoring visits
    • safety management of Clinical Trial, including:

    - data safety monitoring board related-tasks (meeting organization, preparation and conduct)

    - management of adjudications by clinical events committee

    • collaborate in eCRF development and Testing
    • collaborate with Data Management/biometry for Statistical analysis
    • manage core labs’ activities
    • prepare study-related Documentation
    • Data Analysis
    • write clinical study report, present study results
    • ensure Compliance to iso14155, study science)" rel="nofollow">Protocol and company procedures
    • prepare and conduct monthly Compliance meetings with clinical team
    • maintain internal study Documentation (trial master file, site files)
    • coordinate Logistics of investigational devices and study materials
    • support team on administrative tasks (contracts, invoices…)
    • scientific watch, literature review
    • Troubleshooting, beta-Testing of device for product improvement

    Coordination of multi-center European pilot trial for innovative neuromodulation medical device for the treatment of Heart Failure

    • Field Support to sites (France, Belgium, Norway & Serbia) for :

    - Site staff training (investigators, study coordinators)

    - Field technical support in the OR for implantations

    - Field technical support at patient follow-ups

    • Perform monitoring & co-monitoring visits
    • Safety management of clinical trial, including:

    - Data Safety Monitoring Board related-tasks (meeting organization, preparation and conduct)

    - Management of adjudications by Clinical Events Committee

    • Collaborate in eCRF development and testing
    • Collaborate with Data Management/Biometry for statistical analysis
    • Manage Core Labs’ activities
    • Prepare study-related documentation
    • Data analysis
    • Write Clinical Study Report, present study results
    • Ensure compliance to ISO14155, study protocol and company procedures
    • Prepare and conduct monthly Compliance Meetings with clinical team
    • Maintain internal study documentation (Trial Master File, Site Files)
    • Coordinate logistics of investigational devices and study materials
    • Support team on administrative tasks (contracts, invoices…)
    • Scientific watch, literature review
    • Troubleshooting, beta-testing of device for product improvement

Past Experience

  • Clinical research Engineer

    September 2014 --- February 2015

    in charge of the development and Validation of a medical exam (baroreflex assessment) in a Clinical study for a new neuromodulation device

  • Junior Research Engineer

    September 2012 --- February 2013
    taking care of a Research project in bone Tissue Engineering: creation of a biomimetic Cell Culture medium (microfluidic chip), copying biomechanical properties of coral. skills developed in Cell Culture, micro fabrication and microfluidics.

  • Engineering Intern

    January 2011 --- February 2011
    Analysis of environmental data regarding the company, for ISO 14 0001 certification.

Personality

Self Assessment :
CuriosityAttention to detailAdaptabilityCreative thinkingOrganizationProblem solvingProactivity

Knowledge

LinkedIn Assessment :
Biomedical EngineeringProject ManagementClinical researchGCPISO 14155MonitoringCardiologyCardiac Rhythm ManagementNeuromodulationSafetyBiomaterialsPhysiologyCell CultureTissue EngineeringMicrofluidicsBiomechanicsMicrofabricationMatlab

Education

  • Master's Degree in Biomedical Engineering from Université de Technologie de Compiègne in 2014
  • in from Università degli Studi di Salerno in 2011

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Italian
Professional Proficiency

Area / Region

Meudon, France

Others

Driving License
  • Yes

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