Data Integrity Leader

2 weeks ago

Bengaluru, Karnataka, India beBeeRisk Full time ₹ 1,43,76,000 - ₹ 2,14,57,000
Key Job Responsibilities:

The role of Principal Central Monitor requires strategic leadership in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management (RBQM).

This position 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.

Core Duties:
  • Lead Development of Comprehensive Risk-Based Quality Management Plans: Collaborate with cross-functional teams to design and implement customized RBQM plans tailored to each study's unique needs - including identification of critical data & processes, 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 project managers.
  • Advanced Centralized Statistical Monitoring: Design and oversee the implementation of sophisticated 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 project managers.
  • RBQM Meetings: Lead facilitation of 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 and Reporting: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies. Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  • Operational Insights and Continuous Improvement: 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 and proactive remediation. Act as a mentor to more junior Central Monitors, sharing best practices, lessons learned, etc., to improve team performance.

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