Clinical Business Analyst

Accountabilities Clinical Requirements Analysis: Review clinical trial protocols, imaging charters, procedure manuals, compliance reports, and other study documentation to identify and define software requirements. Stakeholder Collaboration: Work closely with clinical, medical imaging, scientific, product, data management, and technology stakeholders to understand workflows, scientific needs, and operational requirements. Functional Specifications: Translate complex clinical, scientific, and therapeutic requirements into detailed functional specifications, configuration requirements, user stories, and workflow documentation. Requirements Management: Gather, document, maintain, and manage study-specific requirements for internal and external software products and services throughout the project lifecycle. Documentation and Reporting: Develop and maintain clear requirements documentation, project reports, stakeholder communications, and materials that support accurate software configuration and implementation. Risk and Dependency Management: Identify risks, dependencies, and potential impacts related to software configuration and delivery, escalating concerns and recommending solutions when appropriate. Software Development and Validation Support: Clarify study requirements and expected system behavior for Development and Validation teams, and contribute to software validation, user acceptance testing (UAT), deployment, and issue resolution. Issue Investigation: Collaborate with relevant teams to investigate software defects, system issues, and support tickets, helping ensure solutions meet clinical and operational expectations. Product Improvement: Partner with Product Management to identify enhancement opportunities, inform new features, and contribute to future technology requirements based on clinical and scientific needs. Project Coordination: Participate in study kick-off meetings and work with Project Management teams to coordinate timelines, manage scope changes, and align delivery expectations. Clinical Data Alignment: Support Clinical Data Management by ensuring consistency across data capture processes, database structures, data transfers, and software configurations. Data Mapping and Reporting: Provide guidance on data mapping, data transfer formats, and reporting requirements to support reliable clinical data workflows. Process Documentation: Contribute to the creation and maintenance of Standard Operating Procedures (SOPs), Quick Reference Guides (QRGs), work instructions, and other process documentation. Industry Knowledge: Stay informed about developments in medical imaging, clinical research processes, healthcare technology, and software solutions relevant to clinical trials. Requirements: A bachelor’s degree in Life Sciences, Computer Science, Healthcare, Information Technology, Biomedical Sciences, Clinical Research, or a related discipline, or an equivalent combination of education and experience. At least 2 years of relevant experience as a Clinical Business Analyst, Medical Writer, Clinical Data Management professional, Project Manager, or in a similar role supporting clinical research technologies. Experience collaborating with business stakeholders, technology teams, and customers in a global or cross-functional environment. A solid understanding of clinical trial processes, clinical research operations, and regulated healthcare environments is preferred. Experience in medical imaging is highly desirable. Familiarity with software requirements gathering, configuration specifications, user stories, workflow documentation, or functional specifications is an advantage. Experience supporting software implementation, validation, testing, or deployment activities. Proficiency in Microsoft Office applications, particularly Word, Excel, PowerPoint, and Outlook. Strong analytical skills, including the ability to interpret complex scientific and technical information and communicate it clearly to different audiences. Excellent written and verbal communication skills in English, with the ability to collaborate effectively across multidisciplinary teams. Strong organizational and project coordination abilities, including managing multiple priorities, meeting deadlines, and maintaining accurate documentation. Excellent problem-solving skills, attention to detail, and a commitment to quality and compliance. The ability to work independently while building productive relationships with colleagues and stakeholders. A proactive, professional, customer-focused mindset and a genuine interest in continuous improvement. Benefits: Competitive compensation: Competitive pay and incentives. Healthcare coverage: Medical insurance. Retirement benefits: Provident fund. Flexible work arrangements: Remote work flexibility, with modern office facilities also available. Employee engagement: Access to employee programs and local events. Meaningful work: Contribute to clinical research technology and medical imaging solutions that support the development of better evidence for medical research. Cross-functional exposure: Collaborate with specialists across clinical, scientific, data management, product, and technology teams. Professional development: Opportunities to expand your knowledge of clinical research, software implementation, medical imaging, and regulated healthcare technology. #J-18808-Ljbffr Jobgether SRL