Amendment Implementation Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Supports the amendment implementation strategy at country and site levels, within a region or globally Supports understanding of amendment scope, classification and timelines Supports requests of country resources in Clarity Collaborates with project teams on amendment planning Discusses financial coverage for an amendment with the Project Lead Tracks amendment related actions and facilitates updates within applicable system(s) Schedules and conducts progress check calls with project teams Updates Principal Investigator Amendment Notification and Amendment Implementation Letters Liaises with the Regulatory Affairs Leads and project teams to assess amendment’ submission requirements and country submission timelines Prepares and distributes the Amendment Progress Report and other applicable study reports to project teams to act on compliance gaps as applicable, directly in systems, providing a deadline for feedback Updates forecasting and actuals for amendment related units according to Clarity monthly deadlines Informs project team members when amendment activities have been completed Supports risk identification and contingency planning pertaining to amendments Introduces roles and responsibilities to project team Requests access to study related systems