Senior Clinical Trials IT Business Analyst

Rochester Regional Health is a healthcare organization seeking a Senior Clinical Trials IT Business Analyst. This role serves as a strategic liaison between Clinical Development and IT, leading the analysis, design, implementation, and optimization of clinical trial technology solutions to support global clinical research operations.

Responsibilities:

• Obtain, analyze, and document detailed business, functional, and technical requirements, translate clinical / non-clinical operational needs into system configurations and technical solutions, develop Business Requirements Documents (BRDs), functional specifications, user stories & acceptance criteria, business process flow diagrams, and data flow diagrams, conduct system impact assessments and gap analyses, support system integration design across enterprise platforms
• Lead or support implementation, upgrade, enhancements, optimization and maintenance of Lab Information Management Systems (LIMS), Lab Information Systems (LIS), Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks (ELM), Validation Lifecycle Management (VLM), configure and support system enhancements, oversee vendor coordination and technical solution delivery, support the management of system change requests and release management processes
• Support Computer System Validation (CSV) and / or Computer System Assurance (CSA) activities such as validation plans, risk assessments, IQ/OQ/PQ test script development/documentation, user requirements & documentation, support the development of System Management Plan (SMP), Trace Matrix and other validation documentation as required, ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, MOH, participate in audit and inspection readiness efforts
• Collaborate with IT architecture teams on system integrations (APIs, HL7, middleware), ensure data integrity, traceability, and consistency across platforms, support data migration, master data governance, and reconciliation processes, partner with operational teams to define reporting requirements
• Lead User Acceptance Testing (UAT), develop test scripts, coordinate execution, support the manage defect tracking & resolution, support regression testing and release validation, facilitate system deployment and post-go-live support
• Act as primary IT liaison for Clinical business stakeholders. facilitate workshops and requirements sessions, support Agile, PMBOK, or hybrid project methodologies, contribute to project plans, risk logs, and status reporting, provide training and change management support

Requirements:

• Bachelor's degree in Life Sciences, Information Systems, Computer Science, or related field
• 3 years of experience in clinical research and/or clinical IT systems (i.e STARLIMS Life Sciences)
• 3 years in Business Analysis within regulated (GxP) environments
• Master's degree (MBA, MS, MPH, MHA) preferred
• CBAP, PMI-PBA, PMP, or Agile certifications
• Experience in global clinical trial environments
• Knowledge of CDISC, SDTM, and clinical data standards
• Experience with reporting tools (Power BI, Tableau, Qlik, Other)
• Familiarity with cloud-based clinical systems (e.g., Veeva, Medidata, Oracle Clinical, BioClinical, etc.)
• Strong understanding of the lab clinical trial lifecycle
• Hands-on experience with LIMS/LIS clinical platforms (i.e STARLIMS Life Sciences)
• Experience with system validation and regulatory compliance
• Familiarity with system integrations and data workflows
• Strong analytical and systems-thinking mindset
• Technical fluency in enterprise applications
• Regulatory compliance expertise
• Cross-functional leadership
• Vendor management skills
• Excellent communication and documentation skills