Domain Specialist – Clinical Data Science

Domain Specialist – Clinical Data Science - (_MS_0012.1)

Share this job as a link in your status update to Linked In.

_MS_0012.1

Domain Specialist – Clinical Data Science

Full Time

Service Operations

We are looking for an experienced

Domain Specialist to 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 primarily within,the CET time zone to ensuresufficient overlap with US-basedbusiness and IT stakeholders.

• ProvideextendedL2businessapplication support for Clinical Data Science(SAS, Spotfire,Metworx, Pinnacle
  21,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) and associated data platforms.
• Support andguideinvestigationandresolution 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, 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.
• Support and guide the team with application upgrades and hotfixes,periodic reviews,validationactivitiesandsystem retirement/decommissioning where applicablein cooperation with the client.
• Coordinate application changes and releases while ensuring compliance with applicable
  
  GxPand 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.
• Ensure appropriate data governance, data integrity, and compliance controls are maintained

• 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, Pinnacle
  21,nQuery,Lab Matrix/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 with supportingregulatory and quality frameworks, including
  
  GxP,EU Annex 11,21 CFR Part 11,GAMP 5,Data Integrity principles.
• Experience with ITIL 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 Service Now 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.

• 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.
• Pinnacle
  21 &nQuery:
  Issue management, validation support, training, and business support…