RBQM Lead: Risk-Based Quality Oversight

ICON Clinical Research

Reading

On-site

GBP 90,000 - 130,000

Full time

8 days ago

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Benefits offered by this job

Annual leave
Health insurance
Retirement planning
LifeWorks EAP (Global)
Life assurance
Flexible benefits

Job summary

ICON Clinical Research is seeking an experienced RBQM Lead to drive risk-based quality oversight across clinical studies. You will lead planning, risk assessments, and cross-functional collaboration to embed RBQM principles from design through governance.

The role requires proactive leadership across Clinical Operations, Data Management, Biostatistics, and other stakeholders to ensure effective monitoring strategies and timely risk mitigation globally.

Qualifications

  • Comprehensive clinical research experience in a global, matrixed environment.
  • Significant RBQM experience across study design, governance, and operations.
  • Strong knowledge of ICH E6 (R2/R3) and ICH E8 applications to RBQM.
  • Excellent communication and stakeholder engagement across functions.

Responsibilities

  • Lead Quality and Risk Management planning aligned with study objectives.
  • Facilitate cross-functional workshops to identify Critical-to-Quality factors and data.
  • Oversee risk assessments, mitigation plans, and monitoring strategies.
  • Drive RBQM governance, inspections readiness, and continuous improvement.

Skills

RBQM expertise
Cross-functional collaboration
Strategic thinking
Communication

Tools

ICH E6 (R2/R3)
RBM concepts

Job description

ICON Clinical Research is seeking an experienced RBQM Lead to drive risk-based quality oversight across clinical studies. You will lead planning, risk assessments, and cross-functional collaboration to embed RBQM principles from design through governance.

The role requires proactive leadership across Clinical Operations, Data Management, Biostatistics, and other stakeholders to ensure effective monitoring strategies and timely risk mitigation globally.

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