RBQM Lead

Role overview

This position sits within ICON’s study delivery and quality framework in Chennai, where the role is focused on risk-based quality management across assigned studies and partnerships. The work is expected to align with ICON’s core values of integrity, inclusion, agility, and collaboration.

Primary responsibilities

Depending on the study or partnership assignment, and working together with the project manager and relevant cross-functional stakeholders, the role may cover setup activities from study award through first patient recruitment plus three months, as well as ongoing maintenance reviews on a quarterly basis.

• Develop the RBQM plan for the study.
• Identify and document critical to quality factors.
• Identify and document critical data and critical processes.
• Lead the initial risk assessment discussions and meetings.
• Make sure risk assessments are completed on schedule and to a high standard.
• Review the critical data path and data flow with the clinical data science lead.
• Review critical data review methods with the clinical data risk analyst, who owns the DRP.
• Contribute to the risk-based monitoring approach, including T-SDV, T-SDR, and any reduced SDV/SDR strategy, in coordination with the CTM.
• Review and contribute to quality thresholds.
• Review and contribute to central monitoring key risk indicators.
• Review functional plans so that risk mitigations are fully addressed.
• Launch ongoing risk reviews and QRRM activities.

Ongoing quality and risk oversight

• Carry out quarterly operational quality checks during maintenance periods.
• Identify, resolve, reduce, and escalate study-level risks and issues proactively through QRRM outputs.
• Confirm that the monitoring strategy is implemented as planned and remains aligned with budget.
• Perform periodic risk assessments whenever critical data, risk factors, milestones, or protocol amendments change.
• Contribute to division- and program-level oversight, quality, and compliance activities tied to RBQM expectations.
• Review study-level quality data to spot trends and emerging risks.
• Track project non-conformance trends.
• Track CAPA trends at both project and site level.
• Review critical and major audit and inspection findings at study and site level.
• Share review outputs with the project manager and functional team leads, and work with them on risk identification, mitigation options, and follow-up actions.
• Report results into governance and oversight dashboards as required.
• Act as an escalation point for study-related quality and risk matters.

Additional information

Applicants are expected to apply ICON’s values in day-to-day work. The source posting indicates a separate application link, which has been intentionally omitted here.

Eligibility

Any graduate may apply.