Business Analyst – Risk-based quality management (RBQM)

Job Title: Business Analyst – Risk-based quality management (RBQM) Location: Onsite, San Jose CA – No remote Job Type: FTE Job Description: Minimum 10 yrs Primary skills:

• 8+ years of experience in Business Analysis, Clinical Systems Support, or Clinical Operations Technology.
• Must understand GXP system validation process
• Must be familiar with AWS environments.
• Working understanding of risk-based quality management (RBQM)
• Experience working with statisticians and Clinical Operations risk managers
• Basic SQL skills for data analysis and data verification.
• Basic Python skills for data analysis.
• Knowledge of clinical operations processes and GxP/regulatory environments is preferred.

 Educational Qualification* Any Bachelor's Degree Experience Range 10+ Years Tagline/Tech Stack Snapshot - BA Experience Role Summary - (To be filled by Practice /DO) We are seeking a Business Analyst with requirement gathering, documentation, and stakeholder engagement within the clinical domain.

• Individual contributor partnering with Business Process Owners and Project Managers to define, document, and deliver complex business and system requirements for the RBQM data pipeline
• Leads requirements refinement, including current/future state analysis, requirements documentation, prioritization, and stakeholder alignment.
• Refine existing user and functional requirements specification.
• Owns User Acceptance Testing planning and execution.
• Partners with the Validation team to ensure testability of equirements and release readiness.

Primary (Must have skills)* - To be Screened by TA Team

• 8+ years of experience in Business Analysis, Clinical Systems Support, or Clinical Operations Technology.
• Must understand GXP system validation process
• Must be familiar with AWS environments.
• Working understanding of risk-based quality management (RBQM)
• Experience working with statisticians and Clinical Operations risk managers
• Basic SQL skills for data analysis and data verification.
• Basic Python skills for data analysis
• Must be able to quickly learn to use new systems
• Strong stakeholder management, communication, and facilitation skills.
• Experience gathering and documenting business requirements and process flows.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong analytical, troubleshooting, and problem-solving capabilities.
• Experience working within Tier 1, 2, and 3 support models.
• Knowledge of clinical operations processes and GxP/regulatory environments is preferred.
• Strong, clear, concise written and oral communication
• Ability to self-motivate and work independently
• Provides proactive status updates
• Experience working for pharmaceutical company in development

Why This Role Matters - New addition (To be filled by Practice /DO) This position is critical for customer who can able to independently handled all BA experience at Offshore What You'll Do/ Job Description of Role* (RNR) - To be Evaluated by Technical Panel (Define it to give more clarity) We are seeking a Business Analyst with requirement gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating business needs into BRDs, user stories, and acceptance criteria, while collaborating closely with development, QA/UAT, and project management teams to ensure successful delivery. Soft skills/other skills - To be Evaluated by Hiring Manager (To define how this will be evaluated) Communication Skills: Communicate effectively with internal and customer stakeholders Communication approach: verbal, emails and instant messages Interpersonal Skills: Strong interpersonal skills to build and maintain productive relationships with team members Provide constructive feedback during code reviews and be open to receiving feedback on your own code. Problem-Solving and Analytical Thinking: Capability to troubleshoot and resolve issues efficiently. Analytical mindset Task/ Work Updates Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps Provides regular updates, proactive and due diligent to carry out responsibilities What Success Looks Like (6–12 Months) - Expected Outcome The Business Analyst will ensure that business requirements are clearly understood, documented, and translated into actionable deliverables, leading to the successful implementation of clinical systems and processes. The role is expected to drive alignment between stakeholders, technical teams, and project managers, ensuring that all solutions meet business objectives, comply with industry standards, and are delivered on time with high quality. . Why Join Us - New Addition To be part of one of the most important engagements for our customer, supporting Business Process Owners and Project Managers to define, document, and deliver complex business and system requirements for the RBQM data pipeline

• Leads requirements refinement, including current/future state analysis, requirements documentation, prioritization, and stakeholder alignment.
• Refine existing user and functional requirements specification.
• Owns User Acceptance Testing planning and execution.
• Partners with the Validation team to ensure testability of equirements and release readiness.

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