Tasks
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.
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
Requirements
•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
•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 feedback
•Apply basic structured thinking to resolve straightforward issues; escalate non-standard problems to senior team members
•Eager to learn new processes/technologies
•Strong attention to detail; follow SOPs and respect data privacy/compliance norms
•Execution Excellence: reliably complete routine, structured work using existing procedures; be prompt, accurate, and compliant in execution; take action to achieve results beyond what is required
•Talent Growth: focus on self-development, openness to feedback, and quickly building skills; embrace continuous learning and actively identify new areas for growth
•Diversity, Equity, & Inclusion: respect and appreciate diverse perspectives; serve as a good team citizen that contributes to overall team effectiveness; value differences and work effectively with individuals of diverse backgrounds
Education/Experience (one of the following):
•Non-Degree with a minimum of 2 years of experience in clinical data programming, data engineering, or related data-management/clinical operations activities
•OR Associate's Degree (minimum preferred) with a minimum of 1 year of experience in clinical data programming, data engineering, or related data-management/clinical operations activities
•OR Bachelor's Degree with prior experience in clinical data programming, data engineering, or related data-management/clinical operations activities preferred
•OR Advanced Degree (Masters or Doctorate) with prior experience in clinical data programming, data engineering, or related data-management/clinical operations activities preferred
Related skill areas: Clinical Databases, Clinical Data Cleaning, Clinical Data Management, Clinical Systems, Data Analysis, Data Documentation, Data Entry, Data Ingestion, Data Literacy, Data Privacy, Data Processing, Data Reporting, Data Review, Data Validation, Data Visualization, Good Clinical Practice (GCP), Python (Programming Language), Root Cause Analysis (RCA), User Acceptance Testing (UAT)
Additional Information
•Employee Status: Regular
•Relocation: Domestic
•VISA Sponsorship: No
•Flexible Work Arrangements: Hybrid
•Shift: Not Indicated
•Valid Driving License: No
•Hazardous Material(s): n/a
