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Trial Activation Approval Specialist I

Pharmaceutical Product Development (PPD)

Mexico City, Mexico

Job Description

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.

Job posted: 2023-05-08

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