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COUNTRY APPROVAL SPECIALIST (CLINICAL TRIAL)

São Paulo - São Paulo

Descrição da oferta de emprego

Country Approval Specialist (Clinical Trial) - - Provides project specific local SIA services and coordination of these projects. - May have contact with investigators for submission related activities. - Key-contact at country level for either Ethical or Regulatory submission-related activities. - Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. - Achieves PPDs target cycle times for site. - May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. - May develop country specific Patient Information Sheet/Informed Consent form documents. - Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. - Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. - Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. - Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
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Detalhes da oferta

Empresa
  • Caderno Nacional
Localidade
Endereço
  • Indeterminado - Indeterminado
Data de publicação
  • 23/12/2024
Data de expiração
  • 23/03/2025
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