Job Description
The Specialist, Data Architect, GDMS Data Integration and Automation executes building, integrating, and maintaining clinical databases / clinical operational systems. In addition, this role executes clinical study systems setup, transformations, integrations, edit checks, reports, and user testing - aligned to standards and study documentation. The Specialist, Data Architect is involved in governance of cross-study programming environments, including management of libraries, code baselines, and terminologies and management of in-life support, change/incident tracking, while driving continuous improvement.
Responsibilities
Programming and reporting
· Design, build, test, and maintain clinical technology systems (e.g., EDC [Electronic Data Capture], RTSM [Randomization & Trial Supply Management], eCOA/ePRO [electronic Clinical Outcome Assessment/ electronic Patient-Reported Outcome]) with moderate guidance using programming / reporting frameworks and automation tools, ensuring quality and compliance.
· Implement and validate complex data logic (edit checks, derivations, dynamic rules) using scripting and validation frameworks, with guidance as needed.
· Propose and implement tools to streamline design, build, and validation processes.
· Apply data literacy to transform collected data into actionable insights.
· Develop advanced reporting solutions (dashboards, listings, visual analytics) using enterprise platforms; incorporate reusable components and role-based access.
Data Engineering
· Configure, test, and validate data sources for integrations and transformations across internal and external systems, using standard procedures and with guidance as needed.
· Collaborate with stakeholders to translate business needs into data and system requirements.
· Troubleshoot straightforward issues in data ingestion and consumption processes and apply standard fixes, escalating non-routine problems to senior colleagues.
· Develop robust data models, semantic layers, and curated datasets; monitor pipelines and enforce quality checks using established procedures with moderate guidance.
Process
· Validate system functionality and ensure compliance with SOPs (Standard Operating Procedures) and regulations.
· Identify process gaps and contribute to continuous improvement initiatives.
· Maintain documentation for changes and incidents to support audit readiness.
· Mentor junior colleagues, share best practices, and support onboarding and training.
· Support release management processes for various business needs across environments (data management/clinical operations), including change control and risk assessment.
· Align stakeholders by translating requirements into technical specs; lead UAT (User Acceptance Testing), capture feedback, and improve reporting standards.
· Partner across teams to turn data and technical findings into clear, actionable stories
· Act as a reliable partner to GDMS (Global Data Management & Standards) and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery.
Technical skills
· Foundational to intermediate-level proficiency in more than one programming language (e.g., SQL, Python, SAS, and R) for implementing clinical data collectors, integrations, transformations, reporting and visualizations
· Proficiency with key tools and platforms used in the data-management ecosystem (e.g., data capture, review/visualization, reconciliation, reporting, or validation tools), with the ability to learn new technologies with guidance.
· Ability to execute technical requirements on straightforward tasks independently, seeking moderate guidance for non-standard work.
· Experienced in scripting and automating data ingestion, cleaning, and reporting processes using established methods, with guidance…