Domain Specialist – Clinical Data Science
Arcondis Group · Kosice
Job description
About the role
We are seeking an experienced Domain Specialist to provide Level‑2 application support for a portfolio of GxP‑regulated clinical data science and clinical operations platforms. The role bridges business teams, IT, quality, validation and external vendors to ensure system availability, compliance and effective data analytics.
Key responsibilities
- Provide extended L2 support for Clinical Data Science tools (SAS, Spotfire, Metworx, Pinnacle21, nQuery) and Clinical Operations platforms (LabMatrix B‑SMART).
- Assist with data analytics, reporting and visualization using 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 integrations.
- Support deviation investigations, CAPAs, audit observations and inspection findings, contributing to audit readiness.
- Coordinate application upgrades, hot‑fixes, validation activities and system decommissioning in collaboration with clients.
- Manage change releases while ensuring GxP and internal quality compliance.
- Create and maintain SOPs, work instructions, support documentation and training materials.
- Drive process improvements and automation initiatives for application support and data management workflows.
Required profile
- 3‑5+ years of application support experience in Clinical Development, Clinical Data Management, Clinical Data Science or Clinical Operations.
- Strong understanding of clinical data structures, workflows, integrations and reporting.
- Experience working in a regulated GxP environment and supporting audit/inspection activities.
- Ability to collaborate with cross‑functional teams and external vendors.
Required skills
- SAS
- Spotfire
- Metworx
- Pinnacle21
- nQuery
- LabMatrix B‑SMART
- Databricks (Genesis)
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Arcondis Group
Kosice
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