Domain Specialist – Clinical Data Science

About the role

We are seeking an experienced Domain Specialist to provide Level‑2 application support for a suite of GxP‑regulated clinical data science and operations tools. The role bridges Clinical Data Science, Clinical Operations, IT, Quality Assurance and external vendors to ensure system availability, compliance and high‑quality reporting.

Key responsibilities

• Provide extended L2 business application support for Clinical Data Science (SAS, Spotfire, Metworx, Pinnacle21, nQuery) and Clinical Operations (LabMatrix B‑SMART) platforms.
• Support data analytics, reporting, visualization, and business intelligence activities through SAS, Spotfire, B‑SMART, Genesis (Databricks) and related data platforms.
• Investigate and resolve incidents, problems, service requests, and application‑related issues, including data flows and analytics.
• Support investigations related to deviations, CAPAs, audit observations, inspection findings, and root‑cause analysis.
• Contribute to inspection and audit readiness for supported computerized systems.
• Act as liaison between business users, IT, QA, validation, data teams and external vendors.
• Assist with application upgrades, hot‑fixes, periodic reviews, validation activities and system retirement/decommissioning.
• Coordinate application changes and releases while ensuring GxP and internal quality compliance.
• Create and maintain SOPs, work instructions, support documentation, knowledge articles and training materials.
• Support users with system functionality, troubleshooting, data analysis, reporting and visualization.
• Analyze application and data issues across upstream and downstream systems and coordinate resolution.
• Drive process improvements, automation initiatives and operational excellence in support and data‑management workflows.
• Ensure data governance, data integrity and compliance controls are maintained.

Required profile

• 3‑5+ years of experience in application support within Clinical Development, Clinical Data Management, Clinical Data Science or Clinical Operations.
• Strong background in Clinical Data Analysis with understanding of clinical data structures, workflows, integrations and reporting.
• Experience working in GxP‑regulated environments.
• Ability to work primarily within the CET time zone to overlap with US‑based stakeholders.

Required skills

• SAS
• Spotfire
• Metworx
• Pinnacle21
• nQuery
• LabMatrix B‑SMART
• Databricks (Genesis)
• GxP compliance
• L2 application support
• Data analytics, reporting and visualization
• Business intelligence
• Data governance