Sr. Manager, RBQM Operations

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Responsible for the implementation of RBQM procedures for assigned studies
• Reviews study protocol and facilitates development of the Study Risk Assessment that defines critical data, critical processes, including quality tolerance limits in collaboration with the study team
• Develops study specific content and leads RBQM training and RBQM kick-off meeti
• Authors and implements the study specific RBQM plan
• Leads risk assessment meetings, engaging cross-functional study team members to identify Critical-to-Quality (CtQ) 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
• Supports and participates in internal and external audits and inspections
• Maintains high quality, consistency, and compliance with RBQM procedures across studies
• 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
• Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
• Supports inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM framework
• May perform line management of other (junior) staff within RBQM Operations

You are:

• 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
• Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work 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)
• 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 quo

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.