Required Skills: CTMS, eTMF, RBQM, EDC
          Job Description
                    Job Title : Business Analyst with Clinical background
 Location(City/ST) : Foster city, CA Onsite
 Work Type(C2C/W2/FT) :FT
 Rate : NA
 Experience :12+ Years
 Client Name :Lenora Systems / Clinical/Lifescience domain client
  
 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 criteria 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
  
 Primary (Must have skills)*
 Business Analysis & Requirements Gathering
 Clinical Domain Knowledge (CTMS, eTMF, RBQM, EDC)
 Documentation (BRD, FRS, User Stories, Acceptance Criteria)
 Technical Collaboration & Requirement Clarifications
 Stakeholder Communication & Coordination
 Testing Support (Test Planning, Test Case Review)
 Project Scope Management & Monitoring
 Deliverable Review & Validation
  
 Secondary Skills (Good To have)*
 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
 Strong analytical and problem-solving skills
 Effective verbal and written communication skills
 Ability to work with cross-functional teams
 Familiarity with data analytics and reporting tools
 Soft skills/other skills (If any)
 Adaptability: Ability to quickly adjust to new technologies, workflows, and environments.
 Communication: Excellent communication skills, both verbal and written.