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Emilie TESTA

Paris

En résumé

Pas de description

Entreprises

  • Cognizant Technology Solutions - Project Manager Life Sciences

    Paris 2012 - maintenant
  • Medtronic - Senior Clinical Data Specialist

    Boulogne-Billancourt 2009 - 2012 Main responsibilities
    • Responsible for supporting the implementation of Clinical Data Management initiatives and related process improvement strategies for clinical studies.
    • Define SOPs and Work Instructions for standardization of Data Management activities.
    • Collaborate and standardize process with the US office.
    • Selection and qualification of CROs.
    • Supervising and monitoring of CRO activities.
    • Audit of eCRF supplier and follow-up of CAPA
    • Participate in protocol review
    • Design and review of eCRFs
    • Set-up of European registry
    • Perform data management tasks on different studies
    • Support monitors and study managers
  • Quintiles - Senior data team lead

    Durham 2003 - 2009 Project Management responsibilities:
    • Coordination of international Phase III studies
    • Interact with Sponsor, team members (CRAS, biostatisticians, programmer, Data managers) and third parties (Lab, ECG, MRI, IVRS…)
    • Negotiate and manage timelines and responsibilities.
    • Manage out-sourcing to distant offices (India, South Africa).
    • Representative of Data Management at project meetings (Investigator's meetings, CRA Trainings, Kick off meetings, Client Meetings).
    • Responsible for financial aspect of Data Management Project (Review of scope of work, monthly reports, invoicing, costing of out of scope, use of people soft tool)
    • Mentor other team members in training and developing data management activities on specific studies.
    • Advanced training of several assistances to use and benefits of e-CRF.


    Data Management experiences:
    Perform all classical data management tasks:
    • CRF design
    • Database set up
    • Database testing
    • Edit checks testing
    • Queries management
    • Coding MedDRA and WHOdrug
    • SAE reconciliation
    • Protocol Deviation Specifications
    • Data Review and preparation for Medical Review
    • Data Handling export / import
    • Database lock

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