Risk-based Study Management Principal role - FSP

Objective / Purpose: Describe at the highest level the team where this job sits and how this role will contribute to the team’s delivery of critical function.

This position reports to a Director of RBQM Operations and is responsible for successfully implementing and coordinating RBQM procedures at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.

Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified.

Responsible for the implementation of RBQM procedures for assigned studies o Reviews study protocol and facilitates development of the Study Risk Assessment that defines critical data, critical processes, and meaningful key risk indicators including quality tolerance limits in collaboration with the study team

• Develops study specific content and leads RBQM training and RBQM kick-off meetings o Authors and implements the study specific RBQM plan
• Leads risk assessment meetings, engaging cross-functional study team members to identify critical to quality risks throughout the trial lifecycle
• Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system
• Performs periodic central monitoring of the aggregate data at the study, region, country, site, and patient levels leveraging available analytics/visualizations in the RBQM system to identify emerging risks and/or issues
• Leads risk review meetings and discussions with study team members to effectively communicate and discuss the findings, facilitates, and encourages robust root cause identification and mitigation strategies
• Ensures corrective actions and preventative actions are properly documented, assigned, and implemented by assigned study team members and/or impacted functions
• Monitors the effectiveness of study risk mitigation actions in reducing the risk signals; makes recommendations to adjust as needed
• Creates signal and trending reports for study teams to support their interpretation of RBQM output
• Partners with the Adaptive Monitoring Excellence team for signals requiring review or adjustment to study level plans for targeted source data verification and source data review
• Maintains up-to-date, accurate documentation of RBQM activities o Supports and participates in internal and external audits and inspections o Maintains high quality, consistency, and compliance with RBQM procedures across studies o Adjusts RBQM plan appropriately based on both anecdotal feedback and data-driven trends in overall RBQM success measures
• Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
  
  

Education & Competencies (Technical and Behavioral): List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.

Education: Bachelor’s degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience.

Experience

• Minimum of 6 years of experience in the pharmaceutical or CRO industry
• Minimum of 2 years of experience in Risk Based Quality Management
• Minimum of 2 years managerial and supervisory experience
• Robust understanding of the drug development process and clinical trial execution
• Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
  
  

Skills

• Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
• Knowledge of RBQM IT systems or other data analytic systems
• Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
• Demonstrated ability to effectively lead cross functional team meetings
• Experience forming cross-functional collaborations; strong interpersonal skills
• Supports a culture of continual improvement and innovation; promotes knowledge sharing
• Ability to influence without authority
• Thinks creatively; challenges the status
  
  

Behavioral Competencies

• Pragmatic and willing to drive and support change
• Comfortable with ambiguity
• Excellent teamwork, organizational, interpersonal, and problem-solving skills
• Assertive and collaborative communication style
• Aptitude for data analytics; analytical mind
• Attention to detail and a critical thinker
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
• Ability to effectively communicate cross functionally with people of various levels