Clinical Risk Manager, Clinical Operations

The Role: The Clinical Risk Manager, Clinical Operations will support the implementation of Deciphera’s Risk-based Quality Management (RBQM) strategy, RBQM processes, and RBQM services by collaborating and partnering with cross-functional trial teams, Clinical Research Organizations (CROs), and stakeholders to ensure compliance with RBQM regulations.What You Will Do:Implements and ensures compliance with RBQM controlled procedural documents (i.e., SOPs, Work Instructions, Templates, and Forms).Leads program and study level RBQM activities, documentation, and escalation when required.Supports cross-functional trial teams with RBQM processes, RBQM plans, and RBQM plan filing.Supports RBQM process improvement initiatives to increase departmental execution and effectiveness.Assists study teams as the RBQM SME in audits and regulatory inspections.Tracks, trends, and reports portfolio, program, and study RBQM KPIs and metrics.Documents, communicates, and escalates RBQM risks to Line Manager and Clinical Operations, as applicable.Demonstrates excitement around the Vison and Mission of Deciphera and the department.Other duties as assigned.