Associate Specialist, Data Architect

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 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.

Enterprise Leadership Skills

· 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

Qualifications & experience

· Non-Degree with a minimum of 2 years of experience in clinical data programming, data engineering, or related data-management/clinical operations activities.

OR

· [Minimum preferred] Associate's Degree 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.

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