Clinical Data Business Analyst

Clinical Data Business Analyst

Foster City, CA 94404 (Onsite)

Direct-Hire / FTE with WinWire

Role Description

• Analyze the information gathered during requirements gathering sessions, communicate findings and get clarifications
• Knowledge of Clinical space and operations; Knowledge in key systems like CTMS, eTMF, RBQM, EDC etc., is highly recommended
• Create requirements specifications document / business requirements documents
• Ability to create User stories and acceptance criterias from the business requirements
• Work with technical team and help in technical specifications and technical design and provide clarifications
• Coordinate with project development teams to share and clarify project requirements
• Coordinate with project QA/UAT teams and help in test planning and test cases creation and review
• Work with project manager to ensure the implementation of project scope and help in planning/monitoring
• Review product/project deliverable to ensure the outcome is meeting business requirements

Experience & Skills

• Business Analysis & Requirements Gathering with Clinical Domain Knowledge (CTMS, eTMF, RBQM, EDC), Clinical Data Science MSP
• Documentation (BRD, FRS, User Stories, Acceptance Criteria); Technical Collaboration & Requirement Clarifications
• Knowledge of regulatory compliance in clinical operations; Experience with Agile & Scrum methodologies
• Proficiency in workflow and process mapping; Hands-on experience with JIRA, Confluence, or similar tools
• Stakeholder Communication & Coordination; Testing Support (Test Planning, Test Case Review)
• Ability to work with cross-functional teams; Familiarity with data analytics and reporting tools
• Adaptability: Ability to quickly adjust to new technologies, workflows, and environments
• Project Scope Management & Monitoring; Deliverable Review & Validation
• Strong analytical and problem-solving skills; Effective communication skills
• BS / BE / BCA / BSE in Computer Science / IT / IS and related experience