Amendment Implementation Specialist

Summarized Purpose :  Completes amendment activities within assigned projects and ensures amendment deliverables meet customer expectations, as well as contracted milestones by providing accurate projections, report updates, and ongoing risk assessments.

Essential Functions :

• 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

Education & Experience :

Knowledge, Skills and Abilities