Project Manager / Business Analyst

Full-Time / Direct-Hire

Foster City, CA 94404 - Onsite

Salary –Market-based on exp.

We are seeking a Project Manager with Business Analyst experience in 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. The role requires excellent communication and problem-solving skills, along with proven ability to work with business teams to refine requirements and ensure alignment with project goals and deliverables. Able to independently handle all PM and customer coordination with BA experience.

• 8+ years of experience in PM / BA, analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders
• 5+ years of proven expertise in the Clinical domain and Clinical operations , including experience with systems like CTMS, eTMF, RBQM, and EDC (highly preferred)
• 5+ years of experience in creating detailed BRDs, user stories, and acceptance criteria, and collaborating with technical teams to define specifications and designs
• 5+ years of experience coordinating with development and QA/UAT teams, supporting test planning, reviews, and ensuring deliverables meet business requirements
• 5+ years of experience working with project managers and business teams to align scope, refine requirements, and support successful project delivery
• Experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps
• Strong interpersonal skills to build and maintain productive relationships with team members

–– Sound knowledge of regulatory guidelines (e.g., 21 CFR Part 11 and GxP compliance), familiarity with Agile/Scrum methodologies and tools like Jira, Azure DevOps, or Client ALM, and strong SQL and data analysis capabilities to support requirement validation and testing. Proficiency in MS Office tools (Excel, PowerPoint, Visio, Project) for documentation and presentations, along with experience in preparing training materials, user guides, and process documentation, will be valuable. The ability to facilitate workshops, requirement sessions, and stakeholder discussions is also expected.

–– 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.