Job DescriptionWe are seeking a highly experienced
Senior Clinical Risk Manager to lead the execution of our Risk-Based Quality Management (RBQM) strategy across a portfolio of complex clinical trials. In this role, you will partner with cross-functional teams, Clinical Research Organizations (CROs), and key stakeholders to proactively identify, assess, and mitigate risks-ensuring high-quality study delivery and compliance with global regulatory requirements.
This is a highly visible role that requires strong leadership, strategic thinking, and deep RBQM expertise to support study and program-level success.
RBQM Execution & Study Delivery- Lead the development and management of study-level risk assessments, including Risk Assessment Categorization Tools (RACTs) and integrated Quality Risk Management Plans (iQRMPs)
- Maintain risk logs and ensure accurate, real-time tracking of study risks
- Facilitate periodic risk review meetings and drive proactive risk identification and mitigation
- Provide expert guidance on site risk levels, study health, and performance trends
- Define and implement study-specific monitoring strategies, including risk-based monitoring approaches such as targeted SDV or centralized monitoring
Risk Oversight & Reporting- Document, communicate, and escalate risks to leadership as appropriate
- Track, trend, and report Key Risk Indicators (KRIs) to support data-driven decision-making
- Partner with internal teams and external vendors to manage risks, mitigations, and issue resolution timelines
- Ensure CROs and service providers adhere to RBQM processes and expectations
- Support or lead program-level RBQM activities and escalations
Governance, Compliance & Continuous Improvement- Serve as a subject matter expert (SME) for RBQM across the organization
- Ensure adherence to SOPs, work instructions, and regulatory requirements
- Contribute to ongoing enhancement of RBQM processes and tools
- Champion a culture of quality, compliance, and continuous improvement
QualificationsRequired Qualifications- Bachelor's degree in a scientific or technical discipline (or equivalent experience)
- 8+ years of Clinical Operations or Development experience, including at least 7 years focused on RBQM
- Prior in-house RBQM experience
- Experience operating at the Manager or Senior Manager level within RBQM
Preferred Experience & Skills- Strong knowledge of RBQM principles, methodologies, and implementation practices
- Deep understanding of global clinical research regulations (e.g., ICH-GCP, 21 CFR Part 11)
- Experience supporting regulatory inspections and audits related to RBQM
- Proven ability to lead process improvement initiatives
- Strong collaboration skills with CROs and external partners
- Excellent communication, problem-solving, and risk management capabilities
Additional InformationDeciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $157,000 - $215,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
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.
