Central Monitoring Lead

The Central Monitoring Lead is a strategic leader within Risk-Based Quality Management (RBQM), responsible for driving data-driven oversight across global clinical trials. This role partners closely with Clinical Operations, Data Management, Biostatistics, and sponsors to identify emerging risks, interpret study data, and recommend proactive mitigation strategies that protect patient safety, ensure data integrity, and support study success.

The successful candidate will bring strong expertise in central monitoring methodologies, clinical trial risk management, and analytical review of study, site, and subject-level data. Acting as both an operational leader and trusted advisor, the Central Monitoring Manager contributes to monitoring strategy development, risk assessment activities, sponsor engagement, and continuous process improvement across a portfolio of clinical studies.

Summary of Responsibilities

• Lead central monitoring activities across multiple global clinical studies and programs.
• Develop and maintain study-specific Central Monitoring Plans and risk management strategies.
• Perform and oversee review of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), study-level surveillance, data quality metrics, and other central monitoring outputs.
• Analyze study, site, and subject-level data to identify quality signals, compliance risks, operational trends, and patient safety concerns.
• Recommend and drive implementation of risk mitigation and monitoring interventions in collaboration with study teams.

• Leverage clinical data, analytics platforms, dashboards, and visualization tools to support proactive risk management.
• Translate complex data findings into actionable insights for study teams and sponsor stakeholders.
• Review critical data trends, protocol deviations, subject eligibility issues, safety events, and data integrity findings.
• Ensure findings are appropriately escalated and tracked through resolution.

• Partner with Clinical Trial Managers, Project Managers, Risk Managers, CRAs, Data Managers, and sponsors to support study delivery.
• Serve as a key customer-facing representative for central monitoring activities and risk management discussions.
• Contribute to proposals, bid defense meetings, and strategic customer presentations.
• Provide expert consultation on RBQM methodologies and monitoring optimization opportunities.

• Support implementation and enhancement of integrated quality risk management processes.
• Contribute to SOP development, process optimization, and adoption of innovative monitoring approaches.
• Drive continuous improvement initiatives focused on efficiency, quality, and data-driven decision making.
• Mentor and coach Central Monitoring professionals and study team members.
  

Preferred Experience

• Extensive experience within Central Monitoring, RBM, RBQM, Medical Data Review, or Clinical Operations.
• Strong understanding of ICH-GCP, protocol compliance, patient safety, and data integrity principles.
• Hands-on experience reviewing KRIs, QTLs, Clinical Data Review outputs, Study Level Surveillance reports, and risk dashboards.
• Experience utilizing data visualization and analytics platforms such as Tableau, Spotfire, Power BI, or similar technologies.
• Demonstrated ability to lead risk discussions with sponsors and cross-functional stakeholders.
• Experience supporting Phase I-IV clinical trials across multiple therapeutic areas.
• Previous leadership, mentoring, or team management experience is highly desirable.

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