Why This Role Stands Out
This role offers an exciting opportunity to lead impactful projects within the dynamic clinical domain, fostering significant career growth and skill development. You'll thrive here if you are an experienced Project Manager and Business Analyst with a passion for translating complex needs into successful solutions and collaborating within a reputable organization. Apply today to leverage your expertise and contribute to innovative clinical technology.
Quick Overview
Seniority
Mid Senior
Work mode
On Site
Location
Santa Clara, CA, United States
Posted
3 weeks ago
ScrumAgileJira
Job Description
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.
Skills / Experience
Secondary Skills / Good to have –– 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.
What Success Looks Like / 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.
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.
Skills / 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
Secondary Skills / Good to have –– 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.
What Success Looks Like / 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.
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