Country Approval Associate

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

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.