Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• 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 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.