| 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 k ey 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. |