Clinical Business Analyst
The Clinical Business Analyst plays a pivotal role in enabling Clario , a part of Thermo Fisher Scientific's Imaging business units to deliver high-impact solutions that improve patient outcomes. This role bridges scientific, operational, and technical teams to ensure study configurations and software solutions are tailored to meet complex clinical trial requirements. You will collaborate across departments to define and document business requirements, support product enhancements, and ensure successful delivery of study-specific technology solutions. Join us in transforming lives by unlocking better evidence.
What You'll Be Doing
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Analyze, interpret, and translate clinical study documentation, including protocols, imaging charters, procedure manuals, and scientific requirements into detailed business and functional software requirements.
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Gather, document, review, and manage study-specific business and system requirements to support accurate software configuration and implementation.
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Develop and maintain client configuration specifications, business requirements documents, workflows, use cases, and supporting project documentation.
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Collaborate with scientific, operational, client-facing, and technology teams to validate requirements and ensure alignment throughout the project lifecycle.
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Act as a liaison between business stakeholders and technical teams to ensure study requirements are clearly understood and successfully implemented.
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Review system configurations and software solutions to confirm compliance with approved study requirements and customer expectations.
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Support software validation, User Acceptance Testing (UAT), installation, deployment, and issue resolution activities.
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Perform impact assessments and support change control activities related to study requirements, system enhancements, and configuration updates.
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Utilize Jira and related tools to manage requirements, user stories, defects, risks, and project documentation.
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Collaborate with Product Management to support product enhancements, new functionality, and continuous improvement initiatives.
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Work closely with Clinical Project Management and Operations teams to support study kickoffs, software build activities, scope changes, and project timelines.
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Partner with Medical & Scientific Affairs teams to ensure scientific requirements and study documentation remain aligned with configured solutions.
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Collaborate with Clinical Data Management teams to ensure alignment between data collection, database structures, data transfers, and study requirements.
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Identify risks, propose mitigation strategies, and escalate issues as appropriate to support successful project delivery.
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Maintain compliance with company Standard Operating Procedures (SOPs), quality standards, and departmental processes.
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Contribute to the development and maintenance of SOPs, work instructions, quick reference guides (QRGs), and other controlled documentation.
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Participate in training programs, internal meetings, and knowledge-sharing initiatives to maintain technical and industry expertise.
What We Look For
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Bachelor’s degree in a related field or equivalent combination of education and relevant experience.
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Minimum of 2 years of experience in clinical research, medical writing, project management, business analysis, clinical data management, or a related role supporting technology solutions in a clinical trial environment.
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Previous experience within clinical trials and understanding of clinical research processes preferred.
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Previous experience supporting medical imaging studies preferred.
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Proven expertise in developing software configuration specifications, business requirements, functional requirements, and related system documentation.
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Demonstrated ability to translate complex clinical study requirements into clear, detailed, and testable software requirements.
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Experience collaborating with software devel