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Country Approval Associate
hace 3 meses
Work Schedule
Other
Environmental Conditions
Office
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 various site startup 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 keycontact at country level for either Ethical or Regulatory submissionrelated activities.
- Works with the startup 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.
