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.

What You Will Bring:

• Bachelor’s degree or equivalent required (scientific or technical discipline preferred).
• Minimum of 3 years of clinical operations/development experience with a minimum of 2 years of direct RBQM experience.
• Prior in-house RBQM experience required.
• Prior RBQM experience at the Manager level preferred.
• Demonstrated understanding of RBQM related theories, processes, and plans.
• Mastery of global regulatory requirements and guidelines for conducting clinical research in accordance with ICH-GCP, 21CFR Part11, and other applicable regulations.
• Experience supporting or participating in GCP inspections (e.g., FDA, EMA, MHRA).
• Excellent critical and analytical thinking skills to understand/analyze complex data.
• Technical ability to use all relevant technology effectively.
• Strong verbal and written communication skills are required.

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.