Senior Clinical Trials IT Business Analyst

Responsibilities

• Obtain, analyze, and document detailed business, functional, and technical requirements
• Lead implementation, upgrade, and maintenance of LIMS, LIS, and other clinical trial systems
• Support Computer System Validation (CSV) and Computer System Assurance (CSA) activities
• Collaborate with IT architecture teams on system integrations using APIs and HL7
• Lead User Acceptance Testing (UAT) and manage defect tracking and resolution
• Act as primary IT liaison for Clinical business stakeholders and facilitate requirements workshops

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 (e.g., STARLIMS)
• 3 years in Business Analysis within regulated (GxP) environments

Preferred Qualifications

• Master's degree (MBA, MS, MPH, MHA)
• CBAP, PMI-PBA, PMP, or Agile certifications
• Knowledge of CDISC, SDTM, and clinical data standards
• Experience with reporting tools like Power BI, Tableau, or Qlik
• Familiarity with cloud-based clinical systems such as Veeva, Medidata, or Oracle Clinical

About the Company

Rochester Regional Health is an integrated health services organization serving Western New York and the Finger Lakes region, including ACM Global Laboratories, a global leader in patient and clinical trials.