Ctry Approval Assoc - Ciudad de México - Thermo Fisher Scientific
Descripción
Trial Activation Approval Specialist I- Essential
- Essential
- Functions
- Prepares, reviews and coordinates, under guidance and local EC submissions 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 keycontact at country level for either Ethical or Regulatory
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,
- manner
- Ensures the local country study files and filing processes are prepared, set up
current regulatory guidelines as applicable to services provided.
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