Country Approval Specialist

Trial Activation Approval Specialist IIEssential 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.