Clinical Business Analyst

This is a fully remote position, open to applicants in India.

📋 Description

• Review clinical trial documentation, such as protocols, imaging charters, procedure manuals, compliance reports, and related study materials, to outline software requirements.

• Collaborate with Medical Imaging business stakeholders to understand operational workflows, scientific needs, and technological requirements.

• Convert scientific, clinical, and therapeutic requirements into functional and configuration specifications.

• Collect, document, maintain, and oversee study-specific requirements for both internal and external software products and services.

• Conduct requirement reviews with scientific teams, project teams, configuration teams, developers, and other stakeholders.

• Create documentation that supports software configuration and implementation.

• Generate and disseminate project reports, requirement documentation, and communications for stakeholders.

• Identify risks, dependencies, and impacts related to software configuration and delivery, and escalate concerns as necessary.

• Offer guidance to Development and Validation teams concerning study requirements and system behavior.

• Assist in software validation, user acceptance testing, deployment activities, and issue resolution.

• Work with teams to troubleshoot software defects, system issues, and support tickets.

• Collaborate with Medical & Scientific Affairs teams to ensure that study documentation aligns with software functionality and operational requirements.

• Aid Product Management by providing insights for enhancements, new features, product improvements, and future technology needs.

• Participate in study kick-off meetings and work alongside Project Management on timelines, scope changes, and delivery expectations.

• Support Clinical Data Management teams by coordinating data capture, database structures, data transfers, and software configurations.

• Offer guidance on data mapping, data transfer formats, and reporting requirements.

• Contribute to SOPs, QRGs, work instructions, and process documentation.

• Stay updated on industry trends, medical imaging technologies, clinical research processes, and software advancements.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Computer Science, Healthcare, Information Technology, Biomedical Sciences, Clinical Research, or a related field is required, or an equivalent combination of experience and education.

• At least 2 years of 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 across business stakeholders, technology teams, and customers in a global setting.

• Familiarity with clinical trial processes, clinical research operations, and regulated healthcare environments is preferred.

• Medical imaging experience is highly desirable.

• Experience in developing software requirements, configuration specifications, user stories, workflow documentation, or functional specifications is preferred.

• Strong analytical abilities with the capacity to comprehend and articulate complex scientific and technical concepts.

• Experience in supporting software implementation, validation, testing, or deployment activities.

• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.

• Strong organizational and project coordination skills, with the ability to manage multiple priorities and meet deadlines.

• Excellent verbal and written communication skills, with the capability to communicate effectively in English.

• Strong problem-solving abilities, attention to detail, and a commitment to quality.

• Ability to work independently while effectively collaborating across multidisciplinary teams.

• A professional, proactive, and customer-focused mindset, with a dedication to continuous improvement.

🏝️ Benefits

• Competitive pay and incentives.

• Provident fund and medical insurance.

• Engaging employee programs and local events.

• Modern office spaces and remote work flexibility.