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    Ctry Approval Assoc - Xico, México - Thermo Fisher Scientific

    Thermo Fisher Scientific
    Thermo Fisher Scientific Xico, México

    hace 1 semana

    Thermo Fisher Scientific background
    Descripción
    Essential Functions and

    Other Job Information:
    EssentialFunctions
    • Prepares, reviews and coordinates, under guidance and local EC submissions inalignment with global submission strategy.
    • Supports preparation, under guidance, of local MoH submissions, as applicable inalignment with global submission strategy.
    • Coordinates, under guidance, with internal functional departments to ensurevarious site start up activities are aligned with submissions activities andmutually agreed upon timelines; ensures alignment of submission process forsites and study are aligned to the critical path for site activation.
    • Achieves PPD's target cycle times for site.
    • May have contact with investigators for submission related activities.
    • May act as a key contact at country level for either Ethical or Regulatorysubmission related activities.
    • Works with the start up CRA(s) to prepare the regulatory compliance reviewpackages, as applicable.
    • Assists in developing country specific Patient Information Sheet/InformedConsent form documents.
    • Assists with grant budgets(s) and payment schedules negotiations with sites.
    • Enters and maintains trial status information relating to SIA activities onto PPD,or client (where contracted) tracking databases in an accurate and timelymanner
    • Ensures the local country study files and filing processes are prepared, set upand maintained as per PPD WPDs or applicable client SOPs.
    • Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, andcurrent regulatory guidelines as applicable to services provided.
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