Director, Study Data Services (Hybrid)

Job Description

Job Summary:

The Director, Data Architect (P-track) works with leadership to define and execute the long-term programming strategy for integration, automation, and analytics across therapeutic areas; establish enterprise standards, and champions continuous improvement. Manage service providers and complex multi-project delivery to full compliance; drive AI/ML and analytics initiatives, provide deep subject matter expertise, shape the DI&A capability roadmap, and plan capacity and competency growth. Provide hands-on technical review, enforce SOPs/standards, manage workload and prioritization, track quality and timelines, and drive best practices (code review, reusable components, test automation) and continuous improvement.

Responsibilities:

Programming and reporting:

• Work with leadership to define and execute the long-term programming and reporting strategy for data integration, reporting, automation, and analytics enablement across therapeutic areas
• Establish and continuously improve programming and reporting standards, frameworks, and operating models anticipating compliance and operational risks to drive scalability, consistency, and strategic outcomes
• Manage service provider partnerships, ensuring adherence to enterprise processes, audit readiness, and quality benchmarks
• Oversee programming and reporting delivery across multiple, highly complex studies / projects; ensuring accuracy, efficiency, and full regulatory compliance
• Provide deep subject matter expertise on programming and reporting strategies, data engineering, and data flow across clinical data systems on more complex studies/ protocols or special projects
• Work with DI&A leadership to help them set strategy for programming and reporting capabilities to be built by DI&A
• Collaborate with senior leadership on long-term capacity planning and competency growth strategies for Data Architects

Data Engineering:

• Own development of critical capabilities (tools, processes, skills) aligned to industry best practices.
• Champion adoption of automation, continuous improvement, and metadata-driven development to enhance productivity and data integrity
• Drive initiatives that leverage emerging technologies (AI/ML, advanced analytics, data virtualization) to enhance data review and reporting efficiency

Process:

• Actively work to solve unique operational challenges with broad organizational impact through direct engagement, facilitation, mentoring, and expert problem-solving techniques.
• Evaluate and implement process/technology improvements that enhance scalability, standardization, and quality; support evolving operating model adoption.
• Partner across teams to translate data and complex technical insights into strategic, actionable outcomes
• Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning priorities, and closing feedback loops to drive high-quality, coordinated delivery.

Technical skills:

• Expert-level proficiency in different programming languages (e.g., Python, R, SAS, SQL) for implementing clinical data collectors, integrations, transformations, visualizations
• Expert knowledge of standards and enterprise data management principles, with the ability to set standards for integration, reuse, and scalability.
• Expert in the interoperability of EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms
• Experience designing or managing cloud-based pipelines (e.g., Azure Data Factory, AWS Glue, Databricks).
• Demonstrated success in managing outsourced programming operations and global delivery partners
• Deep understanding of end-to-end data management governance, clinical operations, operational metrics, and quality frameworks.
• Proven track record implementing risk-based and digital data practices across regions/multiple regions.
• Advanced use of analytical and forecasting tools to inform capacity and operational decisions.
• Oversee regional risk, escalation, and capacity management processes; ensure compliance with local business and labor regulations.
• Operating knowledge of SDLC/CSV, data privacy, and inspection-readiness requirements to govern change at enterprise scale.
• Deep knowledge of drug discovery process, FDA regulations, GxP / ICH guidelines
• Ability to connect business outcomes to technical deliverables

Soft skills:

• Strategic leadership with the ability to align, multi-country / cross-functional teams and stakeholders around shared objectives.
• Strong people leadership, mentoring, and development capabilities across multiple levels and geographies.
• Advanced stakeholder management and negotiation skills, with the ability to influence across functions and seniority levels.
• Ability to lead change, embed innovation, and drive continuous improvement initiatives.
• Resilient and adaptable, with a balance of strategic vision and operational execution.
• Ability to integrate business, operational, and people dimensions into decision-making.

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