What are the responsibilities and job description for the Business Analyst (Clinical Data) position at Hirextra -World's First Staffing Aggregator?
Business Analyst (Clinical Data)
Foster City, CA 94404 (Onsite)
Fulltime / Contract
Job Description
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 Clinical Trial Management System (CTMS), Electronic Trial Master File (ETMF), Risk-based quality management (RBQM), Electronic Data Capture (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
- Work with project manager to ensure the implementation of project scope and help in planning/monitoring
- 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
- Review product/project deliverable to ensure the outcome is meeting business requirements
Experience & Skills
- Experienced in Business Analysis & Requirements Gathering with Clinical Domain Knowledge (CTMS, eTMF, RBQM, EDC), Clinical Data Science
- Documentation (BRD, FRS, User Stories, Acceptance Criteria); Cross functional teams Technical Collaboration and Requirement Clarifications
- Knowledge/experience in 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
Thanks
Lalit
Lalit@hirextra.com
