Risk Based Quality Manager

Role Summary

Leads and manages Risk Based Quality Management (RBQM) activities for assigned clinical studies across all phases and therapeutic areas. Responsible for development and oversight of study risk management plans, collaboration with cross-functional study teams and stakeholders to apply RBQM principles in support of study oversight, issue resolution, and central monitoring.

Responsibilities

• Acts as the Risk Management Lead at the study level and is responsible for leading the cross-functional study team through the development, execution and oversight of study level Risk Management Plans and activities, including:
  • Identification of protocol specific critical data and processes during protocol development
  • Identification of risks relevant to protocol specific critical data and processes
  • Evaluation and ranking of risks
  • Implementation of risk control strategies
  • Selection of appropriate Key Risk Indicators and Quality Tolerance Limits to support risk oversight
  • Guides the study team through planning and execution of RBQM activities for both insourced and outsourced risk management activities in alignment with study objectives, regulatory guidelines, and SOPs
  • Supports timely issue identification and resolution through data analytics and cross-functional collaboration, escalating to senior leaders when applicable
  • Facilitates risk review meetings and discussions with study team members to communicate findings and support signal verification, analysis, and mitigation strategies
  • Supports inspections and internal audits by providing RBQM-related documentation and analysis, in partnership with Clinical Operations and Quality Assurance
  • Maintains accurate RBQM documentation in the TMF in alignment with GCP requirements and company standards
  • Identifies opportunities to improve RBQM processes, tools, and ways of working within Clinical Operations and shares lessons learned and best practices
  • Acts as a change agent, champion, subject matter expert, and point of contact for RBQM methodology to help study teams follow best practices
  • Participates in cross-functional initiatives, projects, or working groups that support continuous improvement of RBQM and trial oversight
  • Mentors less experienced RBQM colleagues where applicable
  • May support central monitoring activities, including development of KRIs, QTLs, and thresholds for central monitoring
  • Performs other duties as assigned

Qualifications

• BA/BS in life sciences or related discipline or RN with 6+ years of related industry experience in drug development, clinical operations, or RBQM/Risk Management, OR
• Master's degree in life sciences or related discipline with 4+ years of related experience
• Ability to interpret clinical trial data and analytics to identify risks and support operational decision-making
• Strong organizational and project management skills with ability to manage multiple priorities across studies
• Ability to work effectively in a matrixed, cross-functional environment and build productive relationships with study team members
• Demonstrated ability to follow established processes while identifying practical opportunities for improvement
• Proven ability to quickly learn new information and communicate requirements to the appropriate individuals
• Effective verbal and written communication skills, including the ability to clearly communicate observations, risks, and recommendations
• Strong communication and interpersonal skills with a collaborative mindset and the ability to influence cross-functional stakeholders
• Solid understanding of RBQM principles and their application within Clinical Operations
• Working knowledge of FDA regulations, ICH guidelines, and GCP requirements relevant to clinical trial conduct, oversight, and RBQM
• Ability to meet multiple deadlines across a variety of projects/programs with a high degree of accuracy and efficiency
• Comfortable developing study-specific KRIs, QTLs, and thresholds for central monitoring
• Ability to identify and escalate issues appropriately and follow-through with corrective actions

Skills

• Analytical interpretation of clinical trial data and analytics to identify risks and support operational decision-making
• Strong organizational and project management capabilities
• Experience working in a matrixed, cross-functional environment and building relationships with study teams
• Effective verbal and written communication skills; ability to clearly communicate observations, risks, and recommendations
• Knowledge of RBQM principles and their application within Clinical Operations
• Knowledge of FDA regulations, ICH guidelines, and GCP requirements relevant to clinical trial conduct and RBQM
• Ability to develop KRIs and QTLs for central monitoring
• Analytical thinking and data-driven decision-making
• Proactive issue identification and escalation with corrective action follow-through