Senior Manager – RBQM Operations

ICON plc

. Implement and coordinate RBQM procedures at the study level .

Posted 10/7/2026full-timeRemote • Brazil, Chile, Costa Rica, Colombia, PeruSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Implement and coordinate RBQM procedures at the study level
Review study protocols and facilitate development of Study Risk Assessments defining critical data, critical processes, and key risk indicators
Develop study-specific content and lead RBQM training and kick-off meetings
Author and implement study-specific RBQM plans
Lead risk assessment meetings with cross-functional study team members throughout the trial lifecycle
Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits, and analytics/visualizations function as required
Perform periodic central monitoring of aggregate data at study, region, country, site, and patient levels
Lead risk review meetings, communicate findings, and facilitate root cause identification and mitigation strategies
Ensure corrective and preventive actions are documented, assigned, and implemented
Monitor the effectiveness of risk mitigation actions and recommend adjustments
Create signal and trending reports for study teams
Partner with the Adaptive Monitoring Excellence team on targeted source data verification and source data review
Maintain accurate RBQM documentation
Support internal and external audits, inspections, and regulatory interactions
Maintain quality, consistency, and compliance with RBQM procedures across studies
Adjust RBQM plans based on feedback and data-driven trends
Identify and share best practices, case studies, failures, and process improvement opportunities
Act as a change agent, champion, subject matter expert, and point of contact for RBQM methodology
May perform line management of junior staff within RBQM Operations

Requirements

What you’ll need

Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work 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)
Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies, and 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
Ability to influence without authority
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
Ability to effectively communicate cross functionally with people of various levels
Legal right to work in the country where the role is based

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Legal right-to-work requirement for the country where the role is based
Reasonable accommodations during the recruitment process