Trial Activation Approval Specialist I
hace 4 semanas
**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.
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Country Approval Asociate
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Desde casa, México Thermo Fisher Scientific A tiempo completoTrial 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. -...
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