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 Requirements 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 Core Competencies 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. Highest-signal resume keywords Clinical Data Management Integrated Data Review Data Quality Management Regulatory Compliance People Management ATS Optimization Keywords Hard Skills Data Review Plans Risk-Based Data Management Governance Frameworks KPI Development Data Quality MetricsClinical Data Analysis SOP Development Change Management Training Material Development Data Visualization Soft Skills Leadership Strategic Thinking Collaboration Influencing Without Authority Problem Solving Industry Keywords 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 #J-18808-Ljbffr Jobtailor