Principal Central Monitor / Risk Manager

Position Summary:

The Principal Central Monitor (Risk Manager) serves as a strategic leader in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management (RBQM). This role is accountable for shaping and executing enterprise-wide RBQM strategies, leading complex risk assessments, and defining key risk indicators (KRIs) in collaboration with senior functional leaders.  Operating at the highest level of subject matter expertise, the Principal Central Monitor oversees the design and implementation of centralized statistical monitoring frameworks, leads RBQM governance forums, and ensures proactive risk detection and mitigation across portfolios. This role provides strategic oversight for high-impact studies and therapeutic areas, guiding cross-functional teams through data-driven decision-making and continuous improvement.  In addition to managing escalations and complex data review activities, the Principal Central Monitor mentors senior & junior colleagues, contributes to global process innovation, and plays a key role in shaping policies, tools & technologies that enhance centralized monitoring capabilities organizationally.

Essential functions of the job include but are not limited to:

• Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach
• Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM
• Advanced Centralized Statistical Monitoring: Design and oversee the implementation of advanced centralized statistical monitoring frameworks. Interpret complex data patterns, lead root cause analyses, and drive data-driven decision-making to enhance study quality and compliance, in collaboration with functional team leads and PM
• RBQM Meetings: Lead facilitation monthly RBQM meetings, bringing together key stakeholders to review and discuss study data, findings, action plans and coordination of data cleaning activities to support study deliverables. Drive the review of key risk indicators (KRIs), data trends, and issue resolution plans. Provide expert guidance on data cleaning prioritization to meet critical study milestones.
• Data Quality Assurance and Oversight: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Mentor teams on proactive data monitoring techniques and lead initiatives to continuously improve data integrity and efficiency.
• Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies
• Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Translate complex monitoring insights into actionable recommendations that drive strategic decisions and study success.
• Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation
• Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance
• Sponsor Engagement and Communications: lead discussions with Sponsors around risk management and proactive data cleaning

Qualifications:  

Minimum Required:

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
• Minimum 10+ years experience in clinical monitoring, clinical trial management or equivalent
• Working knowledge of ICH GCP guidelines and the clinical development process

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Excellent written and spoken English, including strong grammar & scientific vocabulary skills
• Ability to work in a team or independently as required
• Strong understanding of RBQM principles and methodologies.
• Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills
• Demonstrated experience with integrated risk planning & management
• Ability to mentor junior team members

Preferred:

• CRO experience as a Central Monitor

Skills:

• Statistical analysis and data monitoring
• Risk assessment and mitigation
• Report writing and presentation
• Collaboration and teamwork

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