24185 - Clinical Business Analyst

QualityAI is the leading AI-first quality engineering company. We deliver end-to-end quality management services across the business and technology life cycle for enterprise customers who need certainty at Go-Live.

We build and test services and products using AI, working across data, models, platforms, devices, and infrastructure to ensure those systems perform as expected at scale.

Your next career move starts here:Clinical Business Analyst – Netanya.

The role combines a strong understanding of clinical processes with technical business analysis, supporting the full solution lifecycle, from requirements gathering and analysis through configuration, validation, deployment, and ongoing operational support.

Responsibilities

• Partner with R&D Clinical Operations stakeholders to identify business needs, challenges, risks, and opportunities for process improvement.
• Translate business needs into clear user requirements, functional specifications, configuration requirements, and traceable delivery items.
• Assess the impact of proposed changes on processes, roles, data, integrations, reports, SOPs, and training materials.
• Support the implementation and enhancement of clinical applications, including CTMS, eTMF, regulatory solutions, and clinical reporting systems.
• Collaborate with system owners, architects, developers, and vendors on system configuration, interfaces, APIs, data mappings, scheduled jobs, and environment readiness.
• Analyze data flows between source and target systems and troubleshoot integration, data quality, and reconciliation issues.
• Translate functional requirements into actionable work items in tools such as Jira, including detailed acceptance criteria and dependencies.
• Participate in technical design reviews and ensure solutions meet business, security, privacy, and supportability requirements.
• Work within GxP requirements and controlled change management processes, ensuring complete, accurate, and traceable documentation.
• Prepare and contribute to validation deliverables, including URS, functional and configuration specifications, risk assessments, traceability matrices, and IQ/OQ/PQ or UAT test scripts.
• Coordinate test preparation and execution, evidence collection, defect management, and business approvals.
• Ensure compliance with applicable SOPs, data integrity principles, audit readiness, and controlled documentation practices.
• Collaborate with Quality and system owners to address documentation gaps and maintain inspection-ready records.
• Gather and define reporting and dashboard requirements, including metric definitions, source fields, transformation logic, and reconciliation rules.
• Collaborate with BI and data engineering teams working with Power BI, Databricks, SQL-based data stores, and enterprise data lakes.
• Support automation and AI initiatives by defining use cases, controls, expected outcomes, validation requirements, and adoption needs.
• Analyze operational data to identify trends, process bottlenecks, and opportunities for standardization and automation.
  
  

• Bachelor's degree in Information Systems, Engineering, Computer Science, or a related field.
• At least 4 years of experience as a Business Analyst, Systems Analyst, Product Analyst, or in a similar role supporting enterprise applications.
• Experience in pharmaceutical R&D, Clinical Operations, clinical development, or another regulated life sciences environment.
• Proven experience gathering requirements and preparing clear, testable business and functional documentation.
• Hands-on experience with system implementation, enhancements, testing, validation, and production support.
• Working knowledge of GxP, computerized system validation (CSV), data integrity, and controlled change management.
• Experience with clinical systems such as CTMS and eTMF.
• Experience with Veeva Vault is strongly preferred.
• Ability to define business and functional requirements, map processes, write user stories and use cases, establish acceptance criteria, maintain requirements traceability, and manage backlogs.
• Understanding of system integrations, APIs, source-to-target mappings, data models, SQL concepts, data reconciliation, and troubleshooting data-related issues.
• Experience defining requirements for reports and dashboards. Familiarity with Power BI, Databricks, data lakes, or similar analytics platforms is an advantage.
• Experience preparing and executing IQ, OQ, PQ, and UAT activities, including evidence review, defect management, requirements traceability, and validation documentation.
• Experience with Jira, Microsoft 365, Visio, or equivalent process-mapping tools. Familiarity with ServiceNow is an advantage.
• Exposure to workflow automation, low-code solutions, generative AI, or other AI-enabled business capabilities is desirable.
• Fluent English, with strong written communication, presentation, facilitation, and stakeholder management skills.
  
  

• Grow your career in a stable, innovative environment
• Collaborate closely with clients to deliver smart, high-quality solutions
• Make an impact in a dynamic, learning-driven environment
• Be part of a human, value-driven organization that cares