Hybrid RBQM Manager

at ICON plc

• Job title: RBQM Manager
• Job type: Full Time
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Chennai, India

About the role

• RBQM Manager leading implementation of risk management strategies throughout clinical trial lifecycle. Working with global teams to drive quality oversight and regulatory compliance in clinical development.

Responsibilities

• Lead development and execution of Quality and Risk Management planning in alignment with study and program objectives.
• Facilitate cross-functional workshops to identify and document Critical-to-Quality (CtQ) factors, critical data, and critical processes.
• Coordinate and oversee initial and ongoing risk assessments, ensuring timely identification of risks and implementation of mitigation strategies.
• Ensure risk assessments, risk controls, and mitigation plans are complete, actionable, and aligned with regulatory expectations.
• Partner with Clinical Operations, Data Management, Biostatistics, and other stakeholders to review data flows, critical data pathways, and data review requirements.
• Provide strategic input into Risk-Based Monitoring (RBM) strategies, including targeted SDV/SDR approaches and reduced verification models.
• Perform quality gate reviews of functional plans to confirm integration of risk mitigation and monitoring strategies.
• Lead and facilitate Risk Review Meetings (RRMs) and ensure comprehensive documentation of risk evaluations and decisions.
• Oversee ongoing risk surveillance to ensure monitoring strategies remain effective and aligned with study timelines and budgets.
• Ensure risk review outputs provide meaningful insights, trend analysis, and actionable recommendations.
• Update risk assessments based on protocol amendments, emerging signals, or changes to critical data and processes.
• Support program-level and organizational RBQM governance and oversight activities.
• Serve as the primary escalation point for RBQM-related risks and quality issues.
• Contribute to continuous improvement initiatives to enhance RBQM maturity and effectiveness across the organization.

Requirements

• Over 10+ years of comprehensive clinical research experience, collaborating with global teams within a matrixed organizational environment
• Significant experience in clinical research within one or more of the following areas:
• o Risk-Based Quality Management (RBQM)
• o Clinical Operations
• o Central Monitoring
• o Clinical Risk Management
• o Clinical Data Science
• Strong knowledge of ICH E6 (R2/R3), ICH E8, and their application to RBQM.
• Deep understanding of clinical trial processes, data flows, and risk-based monitoring strategies.
• Demonstrated expertise in implementing and operationalizing RBQM frameworks.
• Proven ability to lead cross-functional initiatives and influence stakeholders globally.
• Strong strategic thinking with the ability to translate regulatory expectations into operational practice.
• Excellent communication, stakeholder engagement, and facilitation skills.
• Proactive and solutions-oriented with a strong focus on quality and continuous improvement.
• Ability to operate effectively in complex, global environments.
• Strong critical thinking and risk anticipation capabilities.
• Passion for mentoring teams and strengthening RBQM capabilities across the organization.
• Commitment to fostering an inclusive and collaborative culture

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize 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.