Country Approval Specialist - Sao Paulo, Brasil - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Sao Paulo, Brasil

há 3 semanas

Postado por:

Ana Silva

beBee Recruiter

Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.

Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Keycontact at country level for either Ethical or Regulatory submissionrelated activities.
Coordinates, under guidance, with internal functional departments to ensure various site startup 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 work with the startup CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Enters and maintains trial status information relating to SIA activities onto PPD 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