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Aurélie SAGER

chatillon

En résumé

Mes compétences :
Imagerie médicale
ISO 13485
Gestion de projet
Dispositifs médicaux
Recherche clinique
Gestion de la qualité
DICOM

Entreprises

  • TRIBVN - Business Developement

    chatillon 2012 - maintenant
  • CCBR-SYNARC - Manager, Engineering and Clinical Data Management

    2008 - 2010 RESPONSIBILITIES
    - International Project Management: Coordination of Engineering and Data Management tasks according to clinical trials methodology and GCP. Set-up of oncology software with headquarters’ support (San Francisco). Change management. Planning, resources, quality control, communication, risks management.
    - Team management: 2 Data Managers and 2 Programmers.
    - Operational Management: Set-up and follow-up of operational processes (cardiology, oncology).
    - Leadership/Communication: Team work. Internal and external communication (laboratories). Interaction with key opinion leaders (oncologists, cardiologists, neuro-radiologists).

    MAIN RESULTS
    - Set-up of tools to check quality of clinical data for a trial with 12 sites / 500 patients.
    - Launch of oncology projects in Paris office (RECIST scoring for solid tumors).
    - Set-up of operational processes for a cardiovascular trial including MRI and angiography images. Design of associated scoring e-CRFs (TIMI/TICI/AOL).
  • GE Healthcare - MR Advanced Applications

    2006 - 2006 February 2006 – August 2006 ( 7 months)

    «Brain MR advanced applications: activation imagery and tractography ».
    Configuration and use of hardware and software tools for acquisition, post processing and analysis of functional MRI and diffusion images. Article preparation on Alzheimer’s disease.
    Work at GE MRI Sales & Marketing department and with customers (Hôpital Foch (92), Centre Hospitalier Sainte-Anne (75), Hôpital Bichat (75)). SFNR2006, Spectroscopy Users’ club 2006
  • CCBR - SYNARC - Product Manager

    2006 - 2008 RESPONSIBILITIES
    - Project Management: Leading of developments and improvements of cardiology imaging software.
    - Marketing: Writing of specifications and validation plans according to customers’ needs. Writing of users’ guides and user-satisfaction surveys. Customers’ demos.
    - Training of physicians and technicians (Europe, USA).
    - Design of electronic case report forms (e-CRF) according to customers’ needs.
    - Quality Insurance: Tests, validation and installation of the software. Update of associated quality documentation. Preparation and audits realization (ISO9001).

    MAIN RESULTS
    - Follow-up of about 10 projects including key steps (launching, reading, data transfers to clients).
    - Set-up of an echography project assessing carotids wall thickness on 12 American sites.
    - Design of a measurement tool to assess fat saturation level in liver and spleen on MRI images.
  • INSERM - Trainnee

    PARIS 13 2004 - 2005 September 2004 – February 2005 ( 6 months)

    Purchase and installation of a mouse blood pressure and heart rate equipment.
    Upgrade of a measure system: programming with VB macros on Excel, writing of use instructions for technicians.
  • UPenn - Trainee

    2004 - 2004 5-Month preceptorship at the Hospital of the University of Pennsylvania, Radiology Department, Dr Gee. Use of Analyze software on MRI brain images.

Formations

  • ESCP Europe

    Paris 2010 - 2011 Mastère Spécialisé - 1 an.
    Séminaire international d’un mois « Doing business in Asia » (Mumbai, Shanghai, Beijing).
    Thèse professionnelle: La Big Pharma en Inde et en Chine: éléments pour une comparaison.
  • University Of Pennsylvania (Philadelphia)

    Philadelphia 2003 - 2004 Junior year at the School of Engineering and Applied Science, Bioengineering Department.
  • Université De Technologie De Compiègne (UTC)

    Compiegne 2002 - 2006 Diplôme d'Ingénieur