Associate Director, Clinical Data Reporting

Associate Director, Clinical Data Management Reporting

The Associated Director of Clinical Data Management Reporting will provide strategic leadership for clinical and external data reporting across clinical development unit (CDU) 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 (DRP), study milestone needs, operational metrics, and regulatory requirements.

• Quality and timely delivery of programming outputs such as data review plan listings, exception listings, external data reconciliation reports, operational metrics, and other reports supporting clinical trial quality and risk management.
• Oversight and execution of all data management programming deliverables at the portfolio level.
• Manage internal teams and external vendors, ensuring study milestones are met while safeguarding data quality, integrity, and compliance with global regulatory standards.
• Provide strategic leadership with full accountability for the planning, execution, and delivery of high‑quality clinical data management programming deliverables across the portfolio.
• Develop and maintain robust data reporting standards, scalable programming strategies, and optimize workflows incorporating automation.
• Apply quality‑by‑design principles to all clinical data management programming and reporting deliverables.
• Lead continuous improvement initiatives to modernize clinical data reporting workflows through standardization, process optimization, and automation.
• Proactively identify potential risks and implement mitigation strategies.
• Ensure inspection readiness and regulatory compliance of programming documentation.
• Establish and monitor KPIs to track performance and conformance with programming standards.
• Responsible for line management and performance of Clinical Data Management Reporting staff and mentoring the team.
• Author and contribute to the development of SOPs, work instructions, and departmental training.

• Drive strategic leadership with full accountability for planning, execution, and delivery of high‑quality clinical data management programming deliverables.
• Provide comprehensive oversight of clinical programming and visualization outputs.
• Advance operational excellence by establishing robust data reporting standards and implementing scalable programming strategies.
• Provide subject‑matter expertise in advanced clinical data programming, data extraction and transformation, visualization, and emerging technologies.
• Collaborate with cross‑functional teams to align priorities, streamline workflows, optimize resource allocation, and drive successful delivery.
• Apply quality‑by‑design principles to all deliverables.
• Lead continuous improvement initiatives to modernize reporting workflows.
• Proactively identify potential risks to data quality, integrity, and delivery timelines.
• Ensure inspection readiness and regulatory compliance.