We are looking for an experienced Domain Specialist to support a portfolio of GxP-regulated applications within Clinical Data Science and Clinical Operations.

The idóneo candidate combines strong application support and system lifecycle management experience with a solid understanding of clinical data analysis, data flows, analytics, and reporting processes. The role requires close collaboration with Clinical Data Science and Clinical Operations business teams, IT, Quality Assurance, validation teams, and external vendors.

Preference is to work primarily within EST, but there is also regular availability in CET required in order to communicate with Europe-based stakeholder.

Requirements

Key Responsibilities
- Provide extended L2 business application support for Clinical Data Science (SAS, Spotfire, Metworx, Pinnacle21, nQuery) and Clinical Operations (LabMatrix B-SMART) platforms, ensuring system availability, compliance, and user satisfaction.
- Support data analytics, reporting, visualization, and business intelligence activities through SAS, Spotfire, BSMART,



Genesis (Databricks) and associated data platforms.
- Support and guide investigation and resolution of incidents, problems, service requests, and application-related issues, including issues involving clinical data, integrations, data flows, analytics, and reporting.
- Support and coordinate investigations related to deviations, CAPAs, audit observations, inspection findings, and RCA.
- Contribute to inspection and audit readiness for supported computerized systems.
- Act as a key liaison between business users, IT teams, QA, validation teams, data teams, and external vendors.
- Support and guide the team with application upgrades and hotfixes, periodic reviews, validation activities and system retirement/decommissioning where applicable in cooperation with the client.
- Coordinate application changes and releases while ensuring compliance with applicable GxP and internal quality requirements.
- Create a

📌 Domain Specialist – Clinical Data Science (Colombia)
🏢 Arcondis Group
📍 Colombia