Senior Clinical Trials IT Business Analyst

🕒 May 18

🗽 New York – Remote

🗽 New York – Remote

💵 $100k - $130k / year

⏰ Full Time

🟠 Senior

🧐 Business Analyst

👻 Ghost score 45%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Rochester Regional Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

📚 Education

Healthcare • Healthcare Insurance • Education

Rochester Regional Health is an integrated health services organization serving the people of Western New York. It operates multiple hospitals and healthcare facilities, providing a wide range of healthcare services, including emergency care, primary care, specialty clinics, and urgent care. The organization is committed to medical education and research, offering training programs, residencies, and clinical trials. Rochester Regional Health focuses on comprehensive care with emphasis on treating patients respectfully and meeting their diverse medical needs across all stages of life.

📋 Description

• Serve as a strategic liaison between Clinical Development and Information Technology • Lead analysis, design, implementation, and optimization of clinical trial technology solutions • Obtain, analyze, and document business, functional, and technical requirements • Translate clinical and non-clinical operational needs into system configurations and technical solutions • Develop 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, upgrades, enhancements, optimization, and maintenance of LIMS, LIS, Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks, and Validation Lifecycle Management systems • Configure and support system enhancements • Oversee vendor coordination and technical solution delivery • Support system change requests and release management • Support CSV/CSA activities, validation plans, risk assessments, IQ/OQ/PQ test scripts, user requirements, and validation documentation • Ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, and MOH requirements • Participate in audit and inspection readiness efforts • Collaborate on APIs, HL7, middleware, data integrity, data migration, master data governance, and reconciliation • Define reporting requirements with operational teams • Lead UAT, develop test scripts, coordinate execution, manage defect tracking and resolution, and support regression testing and release validation • Facilitate 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 • 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