Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Supports the amendment implementation strategy at country and site levels, within a region or globallySupports understanding of amendment scope, classification and timelinesSupports requests of country resources in ClarityCollaborates with project teams on amendment planningDiscusses financial coverage for an amendment with the Project LeadTracks amendment related actions and facilitates updates within applicable system(s)Schedules and conducts progress check calls with project teamsUpdates Principal Investigator Amendment Notification and Amendment Implementation LettersLiaises with the Regulatory Affairs Leads and project teams to assess amendment’ submission requirements and country submission timelinesPrepares 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 feedbackUpdates forecasting and actuals for amendment related units according to Clarity monthly deadlinesInforms project team members when amendment activities have been completedSupports risk identification and contingency planning pertaining to amendmentsIntroduces roles and responsibilities to project teamRequests access to study related systems