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Precision for Medicine seeks a Senior Central Monitor to lead quality and integrity oversight of clinical trial data. This role is central to the company's clinical operations, combining statistical expertise with risk management to ensure robust trial execution.
You will lead the development of Risk-Based Quality Management (RBQM) plans, tailored to each study's specific needs, including identification of critical data points, definition of Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs). You'll conduct comprehensive study risk assessments in collaboration with functional team leads and project managers, identifying potential issues and developing mitigation strategies.
Core responsibilities include performing centralized statistical monitoring and data analysis to detect anomalies, trends, and risks; ensuring data accuracy and compliance; and leading monthly RBQM meetings to review study data, document findings, and coordinate data cleaning activities. You'll prepare detailed reports and presentations for sponsors and study teams, and oversee operational metrics including data entry trends, SDV backlogs, and site health trending.
This is an independent contributor role with mentoring responsibilities. You'll mentor junior Central Monitors, sharing best practices and lessons learned to strengthen team performance. You'll also engage directly with sponsors on risk management and proactive data cleaning strategies, and collaborate closely with clinical operations, data management, biostatistics, and other departments.
Required qualifications: Bachelor's degree in life sciences, statistics, data management, clinical operations, or equivalent; minimum 5 years in clinical monitoring, clinical trial management, or equivalent; working knowledge of ICH GCP guidelines and clinical development processes. You must demonstrate strong RBQM principles knowledge, proficiency in statistical analysis and data monitoring tools, excellent written and oral communication skills, and proven ability to mentor junior team members. CRO experience as a Central Monitor is preferred.
