RBM Monitoring Lead

About the Role ICON's RBM Monitoring Lead supports clinical trial management and risk-based monitoring for study programmes, driving quality outcomes and RBQM practices. The role partners with study teams to design and implement site monitoring plans, ensure regulatory compliance, and oversee monitoring activities across trials.

What You'll Do

• Lead RBM strategy meetings and develop study-specific site monitoring plans aligned with risk assessments, including SDV/SDR strategies and site monitoring mitigations.
• Ensure monitoring strategies are configured in technology capabilities and manage Site Monitoring assignments in CDMS/CTMS.
• Provide Site Monitoring training on RBQM and client systems; support creation/delivery of initial and ongoing site monitoring materials and training.
• Serve as primary reviewer of site monitoring visit reports; escalate issues to the Clinical Study Manager as needed.
• Review dashboards to assess site monitoring compliance; triage requests from other functions and manage action items in CTMS.
• Support site monitoring during study conduct, including triggering monitoring visits and assessing co-monitoring or multi-day visit requests; provide back-up as needed.
• Trigger and manage Monitoring Oversight Visits to assess site data quality or site monitoring quality.
• Partner with RBQM Operations to address unresolved centralized monitoring findings and support sites in RBQM processes.
• Periodically assess site monitoring / RBM compliance KPIs and KQIs; summarize results for Study Management and key stakeholders.
• Maintain up-to-date documentation of Site Monitoring activities and serve as CRO counterpart for site monitoring.

What We're Looking For

• University degree in medicine, science, or equivalent; minimum 6 years of experience in pharmaceutical or CRO industry.
• At least 2 years of experience in Site Monitoring / Site Monitoring Management, Risk-Based Monitoring, or Monitoring Excellence roles.
• Strong understanding of drug development and clinical trial execution; knowledge of 21 CFR Part 11 and ICH E6 (GCP).
• Demonstrated ability to drive clinical deliverables and manage competing priorities; ability to develop and lead a team.
• Willingness to travel approximately 25%.
• Familiarity with RBQM concepts, CDMS/CTMS systems, and experience implementing monitoring strategies in technology platforms is a plus.

Compensation & Benefits

• Competitive salary and a comprehensive benefits package.
• Various annual leave entitlements; health insurance offerings; retirement planning options.
• Global Employee Assistance Programme LifeWorks with 24/7 support; Life assurance.
• Flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, travel passes, health assessments, etc.).