Associate Director, Clinical Data Reporting

Role Summary

Associate Director of Clinical Data Reporting provides strategic leadership for clinical and external data reporting across clinical development unit programs. This role focuses on the creation, standardization, and delivery of clinical data programming, external data reconciliation, and reporting deliverables across the portfolio, ensuring alignment with study data review plans, study milestone needs, operational metrics, and regulatory requirements. The incumbent oversees data management programming deliverables at the portfolio level, ensuring data quality, integrity, and regulatory compliance.

The position emphasizes cross-functional collaboration and deep expertise in clinical data programming, external data handling and reconciliation, industry standards, programming methodologies, and clinical data management systems.

• Drive strategic leadership with full accountability for the planning, execution, and delivery of high-quality clinical data management programming deliverables across the portfolio of clinical development units.
• Provide comprehensive oversight of clinical programming and visualization outputs that reveal key insights to support clinical data review, including data review listings, exception listings, external data reconciliation, operational metrics, and other quality reports; ensure accuracy, reliability, and integrity of data supporting clinical studies across the portfolio.
• Advance operational excellence by establishing robust data reporting standards, implementing scalable programming strategies, optimizing workflows incorporating automation, and ensuring consistent delivery of high-quality outputs in accordance with defined user requirement specifications.
• Provide subject matter expertise in advanced clinical data programming, data extraction and transformation, visualization, and emerging technologies to enhance internal data reporting capabilities.
• Collaborate with clinical data management teams, functional line management, and cross‑functional teams to align priorities, streamline workflows, optimize resource allocation, and drive successful delivery of clinical data management programming objectives.
• Apply quality‑by‑design principles to all clinical data management programming and reporting deliverables ensuring that high‑quality outputs are aligned and consistent with risk‑based strategies, and inspection readiness.
• Lead continuous improvement initiatives to modernize clinical data reporting workflows through standardization, process optimization, and automation to improve programming efficiency and scalability.
• Proactively identify potential risks to data quality, integrity, and delivery timelines and implement mitigation strategies to ensure continuity, compliance, and successful delivery of programming objectives.
• Ensure inspection readiness and regulatory compliance of programming documentation; contribute to internal audits and health authority inquiries.
• Establish and monitor KPIs to track performance, conformance with programming standards, and identify opportunities to enhance and/or optimize reporting capabilities.
• Responsible for line management and performance of Clinical Data Management Reporting staff, development of competencies and assessment of annual performance.
• Provide leadership and mentorship to programming teams, fostering skill development, knowledge sharing, and operational excellence.
• Author and contribute to the development of clinical data management programming and reporting SOPs, WIs and departmental training needs.

• Demonstrated ability to oversee the development, validation, and delivery of clinical data management programming and visualization outputs to cross‑functional teams across drug development programs.
• Experience transforming raw clinical data, external data handling, processing, validation, and reconciliation outputs into actionable insights to ensure data accuracy and quality in compliance with industry standards.
• Demonstrated ability to function as a clinical data management programming and reporting SME in solving complex issues and guiding internal teams and external vendors for…