Associate Director, Clinical Data Configuration

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Job Description

GOALS:

The Associate Director, Clinical Data Configuration sits within R&D’s Testing, Innovation, and Data Enablement organization and provides leadership for clinical data configuration, transformation, ingestion, and visualization activities that support clinical trial conduct and development. This role leads Data Configuration Representatives and coordinates cross-functional matrix teams and vendors to define requirements, deliver high-quality work products to timelines, ensure inspection readiness, and advance standards, best practices (including transfer specifications), and related SOPs/training across platforms.

ACCOUNTABILITIES:                                                                                

• Lead and develop a team of Data Configuration Representatives, setting priorities, allocating resources, and driving accountable delivery of data configuration and transformation capabilities that enable clinical trial execution across programs.
• Direct cross-functional/matrix teams and vendor delivery across data configuration, transformation, and visualization platforms; own timelines, quality, and outcomes while ensuring alignment to enterprise data strategy and clinical program needs
• Own stakeholder engagement with data engineering and clinical partners to define requirements, influence solution design, and ensure scalable, reusable data transformation and visualization capabilities across the portfolio.
• Provide end-to-end program leadership for data configuration and transformation initiatives, translating strategic priorities into executable plans and driving delivery across multiple concurrent programs in a complex, matrixed environment.
• Define, govern and promote standards, best practices, and data transfer specifications; own SOP development, implementation, and continuous improvement to ensure consistency, scalability, and compliance across platforms.
• Establish and enforce quality frameworks for internally delivered and vendor-supported outputs, ensuring data integrity, compliance, and adherence to enterprise standards across all deliverables
• Own inspection readiness for data configuration and transformation activities, ensuring audit‑ready processes, documentation, and controls that meet regulatory expectations and minimize organizational risk.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree (e.g., CS, statistics/biostatistics, math, biology/health-related) plus minimum 7 years relevant experience (or equivalent).
• Experience with EDC build/data management or EDC extraction/configuration; strong understanding of clinical data flow (CDMS, vendor devices, CDR).
• Familiarity with data cleaning tools (e.g. Veeva CDB, J Review, Elluminate).
• Visualization/configuration: experience designing visual objects and libraries; programming clinical trial visualization tools.
• Strong clinical trial terminology and data transfer specification knowledge; understanding of SDTM.
• Data/Integration: XML/standards repositories, APIs, ALS, MDR (preferred); ETL/ELT experience; familiarity with AWS/Databricks.
• Programming (preferred): One or more SQL, SAS, R or Python; R Shiny/Python app development.
• Tools/Ways of Working: Microsoft Office.
• Proven project leadership and project management skills including:  Initiative, deadline management, strong