Ctry Approval Assoc - Xico, México - Thermo Fisher Scientific

Descripción

• Essential

• Essential
• Functions
• Prepares, reviews and coordinates, under guidance and local EC submissions inalignment with global submission strategy.
• Supports preparation, under guidance, of local MoH submissions, as applicable inalignment with global submission strategy.
• Coordinates, under guidance, with internal functional departments to ensurevarious 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 Regulatorysubmission-related activities.
• Works with the start-up CRA(s) to prepare the regulatory compliance reviewpackages, as applicable.
• Assists in developing country specific Patient Information Sheet/InformedConsent 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 upand maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, andcurrent regulatory guidelines as applicable to services provided.