Foster City, CA12 days ago
Skills/ Experience 8 years of experience in Business Analysis, Clinical Systems Support, or Clinical Operations Technology; Experienced in analyzing and translating business needs into BRDs, user stories, acceptance criteria, while collaborating closely with development, QA/UAT, and project management teams to ensure successful delivery Experience / Knowledge of Clinical operations processes and GxP/regulatory environments Must understand GXP system validation process and familiar with AWS environments Experience gathering and documenting business requirements and process flows Experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps Experience working within Tier 1, 2, and 3 support models; able to quickly learn to use new systems Experience working for pharmaceutical / Biotech or related company in development Ability to manage multiple priorities in a fast-paced environment; self-motivate and work independently 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 Provides regular updates, proactive and due diligent to carry out responsibilities; Analytical mindset Strong analytical, troubleshooting, and problem-solving capabilities; Communicate effectively with internal and customer stakeholders Good to have / Preferred Understanding of risk-based quality management (RBQM); working with statisticians and Clinical Operations risk managers; Basic SQL, Python skills for data analysis and data verification Job / Role Description 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 requirements and release readiness This position is critical for customer who can be able to independently handled all BA experience Partners with the Validation team to ensure testability of requirements and release readiness 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.