Job Description

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.
  Qualifications