Clinical Monitoring Excellence Lead - FSP EMEA

About the role

The Clinical Monitoring Excellence Lead is a global leadership role at IQVIA responsible for owning, governing and improving end-to-end site management and monitoring processes across the clinical development portfolio. The role ensures monitoring practices are harmonized, efficient, inspection-ready and compliant with ICH-GCP and applicable regulations, and acts as the subject matter expert for site management and monitoring.

Key responsibilities

• Own and govern global site management and clinical monitoring processes, standards, procedures, controls, roles and escalation pathways.
• Drive continuous improvement through process simplification, standardization, automation and operational excellence.
• Lead implementation of modern trial delivery models, risk-based monitoring and innovative technologies.
• Ensure compliance with ICH-GCP, ICH E6(R3), Quality by Design and risk-based quality management frameworks.
• Establish KPIs, KQIs and operational metrics to spot trends, risks and improvement opportunities.
• Support inspection readiness, internal audits, health authority inspections and quality reviews.
• Partner with Clinical Operations, Quality Assurance, Data Management, Regulatory Affairs and CROs, and lead cross-functional change initiatives.
• Maintain process documentation, guidance materials, training curricula and best practices, and advise senior leadership.
• Evaluate emerging trends and support vendor oversight and partnership models.

Required profile

• Bachelor's degree in Life Sciences, Nursing, Pharmacy or a related discipline; advanced degree preferred.
• Minimum 12 years of experience in clinical research, clinical development or clinical operations.
• Significant experience in clinical monitoring, site management or operational excellence in global trials.
• Experience leading global process improvement, operational transformation or quality initiatives.
• Experience in global, matrixed organizations and in supporting regulatory inspections and audit readiness.
• Prior people leadership, mentoring or matrix leadership strongly preferred.

Required skills

• Strong expertise in ICH-GCP, ICH E6(R3), risk-based monitoring, Quality by Design and quality management systems.
• Strategic thinking, process optimization, analytical and data-driven decision-making.
• Change management, stakeholder engagement, leadership and communication across global teams.
• Proficiency with Microsoft Office and clinical technology platforms; excellent written and spoken English.