Sr. Clinical Risk Manager

About the role

We 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.

Responsibilities

• 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
• 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
• 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

Requirements

• 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 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

Pay

The base salary pay range for this role is $157,000 - $215,000. Actual compensation packages will depend on various factors, including depth of experience, education, skillset, overall performance, and location.

Benefits

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