Director, Integrated Data Quality

• Define and lead the Integrated Data Review strategy, operating model, and governance framework across the portfolio
• Oversee consistent execution of Data Review Plans and proactive identification of data quality risks
• Develop standardized data review plan methodologies, templates, processes, and guidance
• Monitor Data Review Plan execution through governance processes, KPIs, and quality metrics
• Partner with Clinical Data Reporting to develop and maintain standardized libraries of visualizations, listings, dashboards, and patient profiles
• Collaborate with the QISS team to translate Risk-Based Data Management methodologies into practical data review approaches and study-level requirements
• Identify data quality, integrity, and delivery-timeline risks and implement mitigation strategies
• Drive continuous improvement and innovation in integrated data review methodologies and technologies
• Develop and maintain SOPs, work instructions, templates, and training materials
• Lead implementation, change management, and training initiatives
• Drive adoption of integrated data review methodologies across clinical and external data domains
• Liaise with internal and external collaborators throughout the drug development process

• 12+ years in Clinical Data Management within the biotechnology, pharmaceutical, or health-related industry
• 5+ years of people management, leadership, and mentoring
• Expert knowledge of clinical data management principles, processes, technologies, and industry best practices
• Expert knowledge of integrated data review principles, data quality management, and critical-to-quality concepts
• Deep understanding of regulatory requirements and industry standards, including ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and global data privacy regulations
• Working knowledge of Risk-Based Data Management principles and their application to Integrated Data Review, including centralized monitoring activities
• Understanding of Risk-Based Quality Management principles and their relationship to integrated data review and centralized monitoring
• Experience establishing, implementing, and evolving integrated data review frameworks, governance models, and methodologies across clinical programs
• Experience identifying critical data and defining risk-based data review strategies
• Experience interpreting and analyzing clinical, operational, and external data to identify trends and potential quality issues
• Experience developing, implementing, and overseeing Data Review Plans and associated governance processes
• Ability to partner with cross-functional collaborators to support risk-based and integrated data review approaches
• Understanding of KPIs and quality metrics used to assess effectiveness and impact of integrated data review activities
• Success solving complex business problems through strategic and critical thinking
• Ability to lead and influence within a matrix organization and drive alignment across cross-functional stakeholders without direct authority

Demonstrates expert knowledge in Clinical Data Management and Integrated Data Review principles, with a strong focus on data quality management and regulatory compliance. Proven ability to lead cross-functional teams and implement effective governance frameworks and methodologies in clinical programs.

• Clinical Data Management
• Integrated Data Review
• Data Quality Management
• Regulatory Compliance
• People Management

• Data Review Plans
• Risk-Based Data Management
• Governance Frameworks
• KPI Development
• Data Quality Metrics Clinical Data Analysis
• SOP Development
• Change Management
• Training Material Development
• Data Visualization

• Leadership
• Strategic Thinking
• Collaboration
• Influencing Without Authority
• Problem Solving

• ICH E6 (R3)
• ICH E8 (R1)
• GxP
• 21 CFR Part 11
• Global Data Privacy Regulations
• Risk-Based Quality Management
• Biotechnology
• Pharmaceutical
• Health-Related Industry
• Integrated Data Review Methodologies