Senior Clinical Trials IT Business Analyst

About this role

Job Title: Senior Clinical Trials IT Business Analyst

Department:Information Technology

Location:Remote

Hours Per Week:40

Schedule:Days; Monday - Friday

SUMMARY

The Senior Clinical Trials IT Business Analyst (Sr. CT IT BA) serves as a strategic liaison between Clinical Development and Information Technology. This role leads the analysis, design, implementation, and optimization of clinical trial technology solutions to support global clinical research operations.

REPONSIBILITIES

• Business & Technical Analysis: 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.
• Systems Implementation & Lifecycle Management: 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.
• Validation & Compliance (GxP): 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, MH...