Domain Specialist – Clinical Data Science

Arcondis Group; Mississippi; On-site; USD 85,000 - 110,000; Full time

Job summary

Arcondis Group is recruiting a Domain Specialist – Clinical Data Science to support GxP-regulated applications across Clinical Data Science and Clinical Operations. The role requires strong lifecycle management and cross-functional collaboration with IT, QA, validation, and external vendors.

The candidate should have 3–5+ years in clinical data analysis, experience with SAS/Spotfire and validation processes, and the ability to work with global teams in a regulated environment.

Qualifications

• 3-5+ years in application support within clinical development, data science or operations.
• Demonstrated background in clinical data analysis, structures, workflows and reporting.
• Experience in a global pharma/biotech or multi-vendor support environment is a plus.

Responsibilities

• Provide extended L2 business application support for Clinical Data Science and Clinical Operations platforms, ensuring availability and compliance.
• Support data analytics, reporting, visualization, and BI activities via SAS, Spotfire, B-SMART, Genesis/Databricks.

Skills

SAS

Spotfire

Data analysis

Clinical data

Communication

Education

Bachelor's degree in IT/CS/Life Sciences

Master's degree

Tools

LabMatrix/B-SMART

Pinnacle21

nQuery

Genesis/Databricks

Job description

Domain Specialist – Clinical Data Science - (RD_QMS_MS_0012.1)

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Requisition #

RD_QMS_MS_0012.1

Job Title

Domain Specialist – Clinical Data Science

Contract Type

Full Time

Category

Service Operations

Overview

We are looking for an experiencedDomain Specialistto support a portfolio ofGxP-regulated applications within Clinical Data Science and Clinical Operations.

The ideal 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 candidateslocatedin, or able to work primarilywithin,the CET time zone to ensuresufficient overlap with US-basedbusiness and IT stakeholders.

Requirements

Key Responsibilities

• ProvideextendedL2businessapplication support for Clinical Data Science(SAS, Spotfire,Metworx, Pinnacle21,nQuery)and Clinical Operations(LabMatrixB-SMART)platforms,ensuring system availability, compliance, and user satisfaction.
• Support data analytics, reporting, visualization, and business intelligence activities through SAS, Spotfire, BSMART, Genesis (Databricks)andassociated data platforms.
• Support andguideinvestigationandresolution ofincidents, 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, andRCA.
• Contribute to inspection and audit readiness for supported computerized systems.
• Act as a keyliaisonbetween business users, IT teams, QA, validation teams, data teams, and external vendors.
• Supportand guide the team withapplication upgrades and hotfixes,periodic reviews,validationactivitiesandsystem retirement/decommissioning where applicablein cooperation with the client.
• Coordinate application changes and releases while ensuring compliance with applicableGxPand internal quality requirements.
• Create andmaintainSOPs, 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.
• Ensureappropriate datagovernance, data integrity, and compliance controls aremaintained

Qualifications,Skillsand Experience

• 3-5+ years of experiencein 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.
• Previousexperience working in a global pharmaceutical or biotechnology organizationis 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 aGxP-regulated pharmaceutical, biotechnology, or lifesciencesenvironment.
• Competence in Computerized System Validation (CSV), SDLC, and System Lifecycle Management.
• Experience withsupportingregulatory and quality frameworks, includingGxP,EU Annex 11,21 CFR Part 11,GAMP 5,Data Integrity principles.
• Experience withITIL processessuch 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 toLabMatrixfor effective monitoring, business process support, user training, change control, and validation management.

Education whichsuitsthe position:

• Preferred field:IT, Computer Science, Data Science, Life Sciences, or a related field
• Follow-up/Higher Professional Education
• University education (Bachelor'sdegree)
• University education (Master'sdegree)
• The position is suitable for a fresh graduate