Director, Study Data Services (Hybrid)

Job Description

The Director, Study Data Services (M-track) leads programming and reporting strategy and delivery across therapeutic areas underneath leadership, ensuring scalable standards, audit-ready execution, and regulatory-compliant outcomes across complex studies and initiatives. This role builds critical programming capabilities and drives automation and emerging technologies to improve efficiency, quality, and data integrity. The Director also manages service provider partnerships and develops high-performing teams through clear direction, coaching, and change leadership.

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.

People management:

• Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
• Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
• Manage an operating budget and optimize spend against priorities.
• Inspire and ensure that team leaders are effectively supporting and empowering their team.

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 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:

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