Job Description
The Associate Specialist, Data Architect, GDMS Data Integration and Automation executes building, integrating, and maintaining clinical databases/clinical operational systems. In addition, the Associate Specialist, Data Architect executes clinical study systems setup, transformations, integrations, edit checks, reports, and user testing – aligned to standards and study documentation.
Responsibilities
Programming and reporting
· Assist in the design, build, test, and maintenance of solutions for clinical technology systems (e.g., EDC [Electronic Data Capture], RTSM [Randomization & Trial Supply Management], eCOA/ePRO [electronic Clinical Outcome Assessment/ electronic Patient-Reported Outcome]) using programming frameworks and automation tools, with guidance from senior team members.
· Implement and validate data logic (edit checks, derivations, dynamic rules) using scripting and validation frameworks.
· Support the development and validation of additional tools to streamline design, build, and validation processes.
· Apply data literacy to transform collected data to enable insights.
· Contribute to developing and maintaining reporting solutions (dashboards, listings, visualizations) using approved tools
Data Engineering
· Assist in configuring, testing, and validating data sources for integrations and transformations across systems.
· Perform routine troubleshooting and resolve data ingestion and consumption issues through debugging and support. Escalate non-standard issues to senior colleagues.
· Develop data models, queries, and optimize data extracts and views for reporting; ensure performance, quality, and version consistency.
Process
· Validate system functionality and ensure compliance with SOPs (Standard Operating Procedures) and regulations, including maintaining documentation for changes and incidents to support audits and inspection readiness.
· Contribute to process improvements, meetings, and special projects.
· Perform unit and integration testing for developed solutions; document test cases and defects; fix issues and prepare releases under change control
· Partner with GDMS (Global Data Management & Standards) and cross-functional stakeholders to confirm requirements, support UAT (User Acceptance Testing) activities, and contribute to sign-off readiness, align priorities, and close feedback loops to ensure high-quality, coordinated delivery
Technical skills
· Knowledge in at least one programming language (e.g., Python, SQL, SAS, R)
· Familiarity with data collection, integration, transformation, reporting, and visualization
· Knowledge of scripting and automation tools for data ingestion, cleaning, and report generation.
· Ability to build simple dashboards and reports using approved tools, including queries, basic data models, and visuals.
· Foundational testing skills for reporting assets (unit/integration), including writing test cases, documenting results, logging defects, and preparing evidence for release.
· Basic knowledge of System Development Lifecycle and validation practices (change control, release checklists, traceability from requirements to test evidence).
· Working understanding of Good Clinical Practice (GCP), data integrity, and audit-ready documentation; familiarity with UAT and sign-off processes by following established procedures and direction.
· Exposure to report performance optimization (query tuning, filters/parameters) and data quality controls for reporting and analytics.
· Ability to connect business outcomes to technical deliverables
Non-technical skills
· Prioritize tasks, meet deadlines, and maintain clean documentation by following established templates.
· Provide clear, timely updates; ask clarifying questions; write concise notes/status.
· Establish positive working relationships across functions; receptive to…