Senior Clinical Trials IT Business Analyst

🕒 Maio 18

🗽 New York – Remoto

🗽 New York – Remote

💵 $100.000 - $130.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧐 Analista de Negócios

👻 Score fantasma 45%

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Rochester Regional Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

⚕️ Seguro de Saúde

📚 Educação

Healthcare • Healthcare Insurance • Education

Rochester Regional Health é uma organização integrada de serviços de saúde que atende a população do oeste de Nova York. Opera múltiplos hospitais e unidades de saúde, oferecendo uma ampla gama de serviços de saúde, incluindo atendimento de emergência, cuidados primários, clínicas especializadas e atendimento de urgência. A organização é comprometida com a educação médica e a pesquisa, oferecendo programas de treinamento, residências e ensaios clínicos. Rochester Regional Health foca em cuidados abrangentes com ênfase no tratamento respeitoso dos pacientes e na satisfação de suas diversas necessidades médicas em todas as fases da vida.

Descrição

• 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

🎯 Requisitos

• 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