
Strategic Data Integrity Leader
5 days ago
As a Strategic Data Integrity Leader, you will drive data quality and patient safety across clinical development programs through advanced centralized monitoring and risk-based quality management. You will serve as a strategic leader in driving data integrity, patient safety, and operational excellence.
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.
">Key Responsibilities">- Lead the Development of Risk-Based Quality Management Plans: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs.
- Conduct Thorough Risk Assessments: Identify potential issues and develop mitigation strategies, in consultation with functional team leads and project managers.
- Design and Oversee Advanced Centralized Statistical Monitoring: Interpret complex data patterns, lead root cause analyses, and drive data-driven decision-making to enhance study quality and compliance.
- Lead Facilitation of Monthly RBQM Meetings: Bring together key stakeholders to review and discuss study data, findings, action plans, and coordinate data cleaning activities to support study deliverables.
- Ensure Data Quality Assurance and Oversight: Proactively monitor and timely intervene to ensure the highest standards of data quality and integrity.
- Collaborate with Clinical Operations, Data Management, Biostatistics, and Other Departments: Support proactive oversight and management and data cleaning for studies.
- Prepare Detailed Reports and Presentations: Translate complex monitoring insights into actionable recommendations that drive strategic decisions and study success.
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