Associate Director, Study Data Services

Job description

Job Description The Associate Director, Study Data Services (M-track) leads and develops a programming and reporting team - set goals, assign work, coach performance, and manage recruiting/onboarding - while communicating status and risks to leadership and partners. Provide hands-on technical review, solutioning support, enforce SOPs/standards, manage workload and prioritization, track quality and timelines, and drive best practices (code review, reusable components, test automation) and continuous improvement. ResponsibilitiesProgramming and reporting • Lead design and deployment of clinical technology system solutions (e.g., for EDC [Electronic Data Capture], RTSM [Randomization and Trial Supply Management], and eCOA/ePRO [electronic Clinical Outcomes Assessment/ electronic Patient-Reported Outcomes]) using programming frameworks and automation tools. • Provide technical oversight for clinical programming, reporting, and data integration across portfolios. • Recommend and implement tools to streamline design, build, and validation processes. • Apply data literacy to design transformation strategies for actionable insights. • Develop advanced reporting solutions (dashboards, listings, visual analytics) with reusable components and role-based access. Data Engineering • Define and govern integration architecture, including data sources and transformation workflows. • Ensure consistent implementation of enterprise standards and reusable assets. • Monitor and troubleshoot data ingestion and consumption for reliability. • Automate and strengthen data engineering processes to reduce risk and improve efficiency. • Develop robust data models, semantic layers, and curated datasets; enforce quality checks. Process • Drive process optimization by identifying gaps and implementing improvements. • Translate strategy into clear priorities, roadmaps, and ways of working for assigned domains. • Lead testing strategies for solutions; automate validation and ensure traceability. • Contribute to resource planning and workload distribution across global teams. • Set documentation and audit standards; ensure compliance through rigorous change management. • Lead cross-functional collaboration, meetings, and enterprise-level improvement programs. • Influence adoption of data standards, tools, and automation for better delivery and decision-making. • Provide leadership, coaching, and mentoring to build capabilities and foster a culture of quality and collaboration. • Support release management across environments; align stakeholders, lead UAT (User Acceptance Training), and improve reporting standards. • Partner across teams to turn data and technical findings into clear, actionable recommendations • Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning on 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. • Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders. Qualifications, Skills & Experience Technical skills ·        Expert-level proficiency in different technology languages (e.g., SQL, Python, SAS, and R) for implementing clinical data collectors, integrations, transformations, visualizations ·        Evidence of experience in architecting and interoperability of EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms ·        Proficiency with key data-management and/or clinical operations tools and platforms (e.g., systems for data capture, review, visualization, reconciliation, and reporting), with the ability to help select, configure, or optimize solutions. ·        Broad understanding of the data-management technology ecosystem (e.g., data capture, review, reconciliation, reporting, analytics, and enabling tools) and how components fit together across the end-to-end process. ·        Experience leveraging automation, scripting, or digital solutions to streamline data-management activities and reduce manual effort. ·        Ability to interpret operational and quality metrics, use analytical/forecasting tools for capacity and scenario planning, and translate insights into clear decisions and actions. ·        Strong understanding of common clinical and regulatory data standards, clinical operational data models, metadata management, and controlled terminologies (e.g., MedDRA, WHODrug) to ensure consistency and submission readiness. ·        Strong understanding of validation, system lifecycle, data-privacy, and System Development Lifecycle Management activities ·        Strong understanding of drug discovery process, FDA regulations, GxP / ICH guidelines ·        Ability to connect business outcomes to technical deliverables Non-technical skills ·        Strong ability to lead teams in a matrixed, global organization while ensuring delivery excellence through effective problem-solving techniques ·        Demonstrated success in coaching, developing, and performance-managing high-performing individuals ·        Builds strong partnerships across technical, business, and quality functions to enhance collaboration and deliver integrated outcomes ·        Balances business needs, resource capacity, and compliance requirements to make sound operational decisions ·        Capable of leading teams through process and organizational transformation with empathy and clarity Enterprise Leadership Skills ·        Execution Excellence | Is results-focused per compliance standards; sets ambitious expectations for accomplishment and ensures others contribute to org strategies by focusing them on the most critical priorities; translates departmental goals into clear expectations ·        Coaching and Development | Manages individual contributors and/or supervisors, provides technical guidance, and develops others through coaching, feedback, and guidance ·        Entrepreneurship | Embraces patient customer focus, ensuring that internal or external customer perspective is the driving force behind strategic priorities, business decisions, org processes, and individual activities; crafts and implements service practices that meet customers' and own organization needs Qualifications & experience Non-Degree or Associate's Degree with a minimum of 10 years' experience working in clinical data programming, data engineering, or related data-management/clinical operations function, and: -    2 years of people management experience. -    Demonstrated deep subject matter expertise in clinical development. OR Bachelor's Degree with a minimum of 8 years' experience working in clinical data programming, data engineering, or related data-management/clinical operations function, and: -        2 years of people management experience. -        Demonstrated deep subject matter expertise in clinical development. OR Advanced Degree (Masters or Doctorate) with a minimum of 4 years' experience working in clinical data programming, data engineering, or related data-management/clinical operations functions, and: -        2 years of people management experience. Demonstrated deep subject matter expertise in clinical development. Additional location(s) Compensation Information: Required Skills: