Business Analyst

The DTF Business Analyst will focus on Digital Trial Foundations (DTF) systems and processes, driving requirements analysis, process improvement, and digital transformation initiatives across the clinical trial landscape. The DTF Business Analyst will play a critical role in bridging business needs and technology solutions. This includes gathering and analyzing requirements, mapping processes, identifying optimization opportunities, and supporting system enhancements across the DTF portfolio. The ideal candidate brings strong business analysis capabilities, combined with experience in clinical or regulated environments, and a pragmatic approach to delivering measurable improvements in trial execution and digital maturity.

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• Lead engagement with business and technical stakeholders to elicit, analyze, and validate requirements.
  
• Develop comprehensive documentation including:
  
• Business requirements
  
• Functional specifications
  
• Use cases and user stories
  
• Process workflows
  
• Ensure alignment between business objectives and technology solutions.
  
• Capture and communicate internal and external customer needs related to system performance and process effectiveness.
  
• Analyses user feedback and identify trends, risks, and improvement opportunities.
  

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• Lead process mapping and gap analysis across clinical trial workflows.
  
• Identify and drive opportunities for digital optimization and automation.
  
• Continuously enhance system functionality and operational efficiency.
  
• Maintain strong awareness of:
  
• Organizational systems landscape
  
• Emerging digital trial technologies
  
• Collaborate across functions, geographies, and vendor teams to implement improvements.
  

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• Identify system risks, issues, and dependencies; elevate appropriately.
  
• Support system testing activities (e.g., UAT, validation support).
  
• Perform data movement and ensure quality checks and data integrity.
  
• Develop and maintain dashboards and metrics to support operational oversight and decision-making.
  

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• Support internal audits and external regulatory inspections.
  
• Ensure alignment with regulatory and quality standards in all deliverables.
  
• Develop and maintain:
  
• Training materials
  
• Job aids and SOP support documents
  
• FAQs and knowledge base content
  
• Promote knowledge sharing and best practices across teams.
  

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• Bachelor’s degree in Science, Information Technology, or a related field (or equivalent experience).
  
• Experience in one or more of the following:
  
• Clinical development
  
• Medical or quality systems
  
• Clinical data or information flow
  
• Strong written and verbal communication skills.
  
• Proven analytical and problem-solving abilities.
  
• Ability to perform root cause analysis and implement corrective actions.
  
• Strong organizational and time management skills.
  
• Ability to manage multiple priorities in a dynamic environment.
  

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• Advanced degree in a relevant discipline.
  
• Experience in a clinical, pharmaceutical, or regulated (GxP) environment.
  
• Hands‑on experience with clinical trial systems and digital platforms.
  
• Strong stakeholder management and engagement skills.
  
• Experience with:
  
• Requirements management tools
  
• Process modelling frameworks (e.g., BPMN)
  
• Project management methodologies
  
• Understanding of regulatory and quality frameworks governing clinical trials.
  

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• Influence cross‑functional teams
  
• Build consensus and resolve conflicts
  
• Strong critical thinking and decision‑making skills.
  
• High adaptability and learning agility. xcfaprz
  
• Customer‑focused mindset with strong collaboration skills.