Country Approval Asociate

Trial Activation Approval Specialist I

Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. - Coordinates, under guidance, with internal functional departments to ensure Consulta de detalles: Petición de puesto: R-01203605 Trial Activation Approval Specialist I 11:20 04/09/2023 Página 2 de 3 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 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 Regulatory submission-related activities. - Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. - Assists in developing country specific Patient Information Sheet/Informed Consent 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 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.