Job Description of Role* (RNR)
(Mandatory - Minimum 500 words) | 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 accpetance criterias from the business requriements
Work with technical team and help in technical specifications and technical design and provide clarificaitons
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 |
Expierence Range | |
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. |