Senior Clinical Trials IT Business Analyst (Clinical Trials IT)

Location: Remote; role associated with Rochester, New York, United States

Salary: $100,000–$130,000 per year

Company

hirify.global operates in clinical laboratory and clinical research services.

What you will do

• Act as the strategic IT liaison between Clinical Development and Information Technology.
• Analyze and document business, functional, and technical requirements, including BRDs, functional specifications, user stories, acceptance criteria, and process diagrams.
• Lead or support implementation, upgrades, enhancements, optimization, and maintenance of LIMS, LIS, Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks, and Validation Lifecycle Management systems.
• Support system integrations, data migration, master data governance, reconciliation, reporting requirements, and data integrity across enterprise platforms.
• Lead UAT, develop test scripts, coordinate defect resolution and regression testing, and support deployment and post-go-live activities.
• Facilitate stakeholder workshops and contribute to project plans, risk logs, status reporting, training, and change management.

Requirements

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or a related field.
• At least 3 years of experience in clinical research and/or clinical IT systems.
• At least 3 years of business analysis experience in regulated GxP environments.
• Experience with system validation, regulatory compliance, and documentation, including 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDPR, and MOH requirements.
• Strong analytical, systems-thinking, communication, documentation, cross-functional leadership, and vendor management skills.

Nice to have

• Master’s degree such as MBA, MS, MPH, or MHA.
• CBAP, PMI-PBA, PMP, or Agile certification.
• Experience in global clinical trial environments and knowledge of CDISC and SDTM standards.
• Experience with Power BI, Tableau, Qlik, cloud-based clinical systems, and LIMS/LIS platforms such as STARLIMS Life Sciences.
• Familiarity with clinical trial lifecycles, system integrations, data workflows, and regulatory compliance.

Culture & Benefits

• Remote work arrangement.
• Full-time schedule of 40 hours per week, Monday through Friday during daytime hours.
• Sedentary work with reasonable accommodation available for reported physical requirements.