What You’ll Do:
• Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy.
• Support preparation, under guidance, of local MoH submissions, as applicable in
• alignment with global submission strategy.
• Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieve company’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.
• Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• Assist in developing country specific Patient Information Sheet/Informed Consent form documents.
• Assist with grant budgets(s) and payment schedules negotiations with sites.
• Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner
• Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.