Overview

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

The adecuado 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 will be given to candidates located in, or able to work primarily within, the CET time zone to ensure sufficient overlap with US-based business and IT stakeholders.

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 and maintain SOPs,



work instructions, operational procedures, support documentation, account concepts, knowledge articles, and training materials.
- Support business users with system functionality, troubleshooting, data analysis, reporting, and visualization.
- Analyze application and data-related issues across upstream and downstream systems and coordinate their resolution with the relevant technical or business teams.
- Drive process improvements, automation initiatives, and operational excellence activities related to application support and data management workflows.
- Ensure appropriate data governance, data integrity, and compliance controls are maintained

Qualifications, Skills And Experience

- 3-5+ years of experience in application support within Clinical Development, Clinical Data Management, Clinical Data Science, or Clinical Operations.
- Demonstrated background in Clinical Data Analysis and understanding of clinical data structures, workflows, integrations, and reporting.
- Previous experience working in a global pharmaceutical or biotechnology organization is preferred.
- Experience working in a managed services or multi-vendor support environment is an advantage.
- Hands-on experience with one or more of the following platforms: SAS, Spotfire, Metworx, Pinnacle21, nQuery, LabMatrix/B-SMART, Databricks, or comparable data platforms.
- Experience supporting applications in a GxP-regulated pharmaceutical, biotechnology, or life sciences environment.
- Competence in Computerized System Validation (CSV), SDLC, and System Lifecycle Management.
- Experience with supporting regulatory and quality frameworks, including GxP,



EU Annex 11, 21 CFR Part 11, GAMP 5, Data Integrity principles.
- Experience with ITIL processes such as: incident, problem, change, release, and service request management.
- Strong knowledge of CAPA, Deviations, Root Cause Analysis, Regulatory Inspection Readiness, Data Governance, and Data Integrity.
- Experience with ServiceNow or comparable ITSM platforms.
- Strong analytical and troubleshooting capabilities, particularly for issues involving data flows, integrations, reporting, and analytics.
- Ability to translate business requirements and clinical data needs into technical or application support activities.
- Fluent English is essential for effective stakeholder management and clear communication.
- Ability to work independently and coordinate activities across business, IT, Quality, and external vendors.

Technical & Functional Expertise Requirements:

- SAS: Platform upgrades and hotfix coordination, validation and periodic review support, and clinical/analytics support on data automates flow from upstream systems.
- Spotfire: Data visualization and reporting support, business user training, and troubleshooting.
- Pinnacle21 & nQuery: Issue management, validation support, training, and business support activities.
- LabMatrix (B-SMART): Data integration oversight, data analysis from Genesis to LabMatrix for effective monitoring, business process support, user training, change control, and validation management.

Education which suits the position:

- Preferred field: IT, Computer Science, Data Science, Life Sciences, or a related field
- Follow-up/Higher Professional Education
- University education (Bachelor's degree)
- University education (Master's degree)
- Postgraduate (Doctorate)

Language Skills

- English – Upper Intermediate (C1)

The position is suitable for a fresh graduate
- No

Time zone: Flexibility and availability to work during CET (Central European Time) hours is expected.

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