Director, Study Data Services (Hybrid)

Job description

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. Able to engage in service providers, leadership, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure. Enterprise Leadership Skills: Business Savviness​ | Anticipate business and regulatory issues and shape strategy accordingly; connect technical expertise to organizational and industry context to make strategic recommendations​ Influence​ | Lead large teams / projects, help shape departmental strategy, influence leaders, peers, and cross-functional partners to align on decisions and strategic direction​ Change Catalyst​ | Drive improvements (e.g., organizational and cultural changes) with broader impact; demonstrate adaptability and ability to collaborate with others to make change successful; help others overcome resistance to change​ Qualifications & experience: Bachelor's Degree with a minimum of 10 years’ experience working in in clinical data programming, data engineering, or related data-management/clinical operations functions, as well as: Demonstrated deep subject matter expertise in clinical development. Advanced Degree (Masters or Doctorate) with a minimum of 8 years’ experience working in clinical data programming, data engineering, or related data-management/clinical operations functions, as well as demonstrated deep subject matter expertise in clinical development. #eligibleforERP #clinicaltrialjobs Required Skills: Change Management, Clinical Data Management, Clinical Study Protocols, Data Management, Data Reporting, Data Validation, Delivery Management, Regulatory Compliance, Stakeholder Management, Strategic Leadership Preferred Skills: Deliverables Management, End-to-End Testing, Operational Decisions Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environ