24185 - Clinical Business Analyst

About the company

Join QualityAI and take part in innovative and impactful work in the technology worlds. As a strategic partner for AI-based Quality Engineering, we assist organizations in planning, developing, and operating critical systems and products with speed and confidence. With us, you can integrate into significant projects, be exposed to advanced technologies, and develop in a stable, professional, and human environment.

Your tasks

The role combines a deep understanding of clinical processes with the analysis of business and technological systems, while providing support throughout the entire solution lifecycle – from requirements gathering and analysis, through configuration, validation, and implementation, to ongoing operational support.

The role includes

• Working with stakeholders in R&D and Clinical Operations departments to identify business needs, challenges, risks, and opportunities for process improvement.
• Translating business needs into clear user requirements, functional specifications, configuration requirements, and actionable tasks throughout the development and implementation process.
• Examining the impact of proposed changes on processes, roles, data, interfaces, reports, Standard Operating Procedures (SOPs), and training materials.
• Supporting the implementation and upgrading of clinical systems, including CTMS, eTMF, regulatory solutions, and clinical reporting systems.
• Working in collaboration with system owners, architects, developers, and vendors on system configuration, interfaces, APIs, data mapping, scheduled tasks, and workspace readiness.
• Analyzing data flow between source systems and target systems, and resolving issues related to integrations, data quality, and data mapping.
• Translating functional requirements into detailed work tasks in tools such as Jira, including defining acceptance criteria and dependencies.
• Participating in technical design reviews and ensuring the alignment of solutions with business requirements, information security, privacy, and system maintainability and support capabilities.
• Working in accordance with GxP requirements and controlled change management processes, while ensuring full, accurate, and traceable documentation.
• Preparing and writing validation documents, including URS, functional specifications, and configuration specifications, risk assessments, traceability matrices, and IQ/OQ/PQ or UAT test scenarios.
• Coordinating test preparation and execution, evidence collection, defect management, and obtaining approvals from business stakeholders.
• Ensuring compliance with relevant Standard Operating Procedures (SOPs), data integrity principles, audit readiness requirements, and controlled documentation procedures.
• Working with the Quality department and system owners to address documentation gaps and maintain audit-ready records.
• Gathering and defining requirements for reports and Dashboards, including defining metrics, source fields, transformation logic, and data mapping rules.
• Working with BI and data engineering teams using Power BI, Databricks, SQL-based data stores, and enterprise Data Lakes.
• Supporting automation and Artificial Intelligence initiatives by defining use cases, controls, expected results, requirements, validation, and implementation needs.
• Analyzing operational data to identify trends, process bottlenecks, and opportunities for standardization and automation.

Requirements

• Bachelor's degree in Information Systems, Engineering, Computer Science, or another relevant field.
• At least 4 years of experience in a Business Analyst, Systems Analyst, Product Analyst, or similar role supporting enterprise systems.
• Experience in the pharmaceutical R&D field, Clinical Operations, Clinical Development, or another regulated Life Sciences field.
• Proven experience in requirements gathering and preparing clear, detailed, and testable business and functional documents.
• Practical experience in system implementation, upgrades, testing, validation, and system support in a Production environment.
• Familiarity with GxP requirements, Computerized System Validation (CSV), data integrity, and controlled change management.
• Experience working with clinical systems such as CTMS and eTMF.
• Experience working with Veeva Vault – a significant advantage.
• Ability to define business and functional requirements, map processes, write User Stories and Use Cases, define acceptance criteria, maintain requirement traceability, and manage Backlogs.
• Understanding of system integrations, APIs, data mapping between source and target systems, data models, SQL concepts, data mapping, and data-related troubleshooting.
• Experience in defining requirements for reports and Dashboards. Familiarity with Power BI, Databricks, Data Lakes, or similar data analysis platforms – an advantage.
• Experience in the preparation and execution of IQ, OQ, PQ, and UAT testing, including evidence review, defect management, requirement traceability, and validation documentation.
• Experience working with Jira, Microsoft 365, Visio, or similar process mapping tools. Familiarity with ServiceNow – an advantage.
• Familiarity with workflow automation, Low-Code solutions, Generative AI, or AI-based business capabilities – an advantage.
• Very high level of English, including writing, communication, presentation, facilitating discussions, and managing interfaces with stakeholders.

Other

We are looking for a Clinical Business Analyst for our team in Netanya.