Country Approval Asociate

Job Description

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.