# Clinical Monitoring Excellence Lead **Company**: IQVIA **Location**: Madrid **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Madrid-Spain/Clinical-Monitoring-Excellence-Lead---FSP-EMEA_R1579159-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/job/clinical-monitoring-excellence-lead-dd9fabcd-a26/ ## Description The Clinical Monitoring Excellence Lead is a global leadership role responsible for the ownership, governance, optimization, and continuous improvement of end-to-end site management and monitoring processes across the clinical development portfolio. The role ensures that monitoring practices are globally harmonized, efficient, inspection-ready, and compliant with ICH-GCP, applicable regulatory requirements, quality standards, and evolving industry expectations. Key Responsibilities: - Own and govern global site management and clinical monitoring processes, standards, procedures, controls, roles, responsibilities, and escalation pathways. - Drive continuous improvement initiatives focused on process simplification, standardization, automation, and operational excellence across the monitoring ecosystem. - Lead implementation of modern clinical trial delivery models, risk-based monitoring approaches, and innovative technologies to improve performance and quality. - Ensure global processes remain compliant with ICH-GCP, ICH E6(R3), Quality by Design principles, risk-based quality management frameworks, and applicable international regulations. - Establish and oversee key performance indicators (KPIs), key quality indicators (KQIs), and operational metrics to identify trends, risks, and improvement opportunities. - Provide strategic leadership for inspection readiness initiatives and support internal audits, health authority inspections, and quality reviews. - Partner with Clinical Operations, Quality Assurance, Data Management, Regulatory Affairs, CROs, and other stakeholders to drive consistent process execution globally. - Lead cross-functional process transformation and change management initiatives to ensure successful adoption of new ways of working. - Develop and maintain process documentation, guidance materials, training curricula, job aids, and best practices. - Serve as the subject matter expert for site management and monitoring processes, providing consultation and strategic recommendations to senior leadership. - Evaluate emerging industry trends, technologies, and regulatory developments to inform future-state monitoring strategies. - Support vendor oversight and partnership models to ensure alignment with process standards and quality expectations. - Promote a culture of quality, continuous improvement, operational excellence, and knowledge sharing across global teams. Qualifications: - 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 within global clinical trials. - Demonstrated experience leading global process improvement, operational transformation, or quality-focused initiatives. - Strong expertise in ICH-GCP, ICH E6(R3), risk-based monitoring, Quality by Design, and quality management systems. - Experience working within global, matrixed organizations and collaborating across multiple regions and cultures. - Proven track record of driving organizational change and influencing stakeholders at multiple levels. - Experience supporting regulatory inspections, audits, and inspection readiness programs. - Prior people leadership, mentoring, or matrix leadership experience strongly preferred. Skills & Competencies: - Strong strategic thinking and process optimization capabilities. - Advanced analytical and data-driven decision-making skills. - Deep understanding of clinical trial monitoring methodologies and site management best practices. - Expertise in process governance, risk assessment, and quality management. - Strong change management and stakeholder engagement capabilities. - Ability to identify operational inefficiencies and implement scalable improvements. - Excellent problem-solving, critical-thinking, and decision-making skills. - Strong leadership and influencing abilities across global, cross-functional teams. - Outstanding presentation, communication, and facilitation skills. - High level of cultural awareness and ability to work effectively across geographies. - Strong organizational skills with the ability to manage multiple priorities and complex initiatives simultaneously. - Self-motivated, proactive, and comfortable operating in a highly dynamic environment. - Proficiency with Microsoft Office applications and clinical technology platforms. - Excellent written and verbal English communication skills. For more fresh new jobs, check out [yubhub.co](https://yubhub.co/). ## Skills ### Required - ICH-GCP - ICH E6(R3) - Quality by Design - risk-based monitoring - quality management systems - clinical trial monitoring - site management - process governance - risk assessment - change management - stakeholder engagement ### Nice to have - Microsoft Office applications - clinical technology platforms --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Madrid-Spain/Clinical-Monitoring-Excellence-Lead---FSP-EMEA_R1579159-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)