Overview
On Site
$120,000 - $130,000
Full Time
Skills
Clinical Trial Management System
CTMS
eTMF
RBQM
EDC
Clinical Data
Clinical Data Science
Requirements Analysis
Requirements Elicitation
Regulatory Compliance
Quality Assurance
Business Analysis
Agile
JIRA
Test Cases
Test Plans
Testing
User Stories
Reporting
Conflict Resolution
Analytical Skill
Communication
Job Details
Job Title: Business Analyst (Clinical Data)
Location: Foster City, CA 94404 (Onsite)
Direct-Hire / FTE
Required Skills: CTMS, eTMF, RBQM, EDC, Clinical Data Science MSP
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 a requirements specifications document/business requirements document
- Ability to create User stories and acceptance criteria from the business requirements
- Work with the technical team and help in technical specifications and technical design,n 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 the project manager to ensure the implementation of project scope and help in planning/monitoring
- Review the product/project deliverables 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
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