Project Manager / Business Analyst

Full-Time / Direct-Hire Foster City, CA 94404

We are seeking a Project Manager/Business Analyst with Clinical domain knowledge, requirement gathering, documentation, and stakeholder engagement within the Clinical and/or Regulatory domain. Experienced in Project management and in analyzing and translating business needs into BRDs, user stories, and acceptance criteria, while collaborating closely with development, QA/UAT to ensure successful delivery. 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. Communicate effectively with internal and customer stakeholders; Capability to troubleshoot and resolve issues efficiently.

• Coordinate and facilitate discussions across Clinical Systems and Operations, and cross-functional stakeholders to align on requirements, timelines, risks, and action items
• Develop and track integrated project timelines, provide status updates, and manage activities using Azure DevOps (ADO)
• Collaborate with Study Managers, Business teams, and Support Leads to define technical tasks, resource estimates, and support processes
• Gather, analyze, document, and manage business requirements, use cases, SOPs, training materials, and process documentation
• Provide day-to-day application support, ticket management, customer support, and resolution of business and system-related issues within SLA timelines
• Deliver user training, knowledge transfer sessions, and support cross-functional teams to ensure smooth system and process operations
• Participate in Tier 1, 2, and 3 Clinical Systems support, including troubleshooting technical/functional issues and supporting Custom App/SaaS application
• Provides regular updates, proactive and due diligent to carry out responsibilities; Ability to manage multiple priorities in a fast-paced environment

Experience / Skills

• 8+ years of experience in PM / Business Analysis with Risk-Based Quality Management (RBQM), CTMS Support and/or Clinical Systems Portfolio Support
• Experience working with Clinical Systems / Clinical Trial Management System (CTMS) platforms
• Knowledge on RBQM, CTMS Support, Clinical Systems Portfolio Support along with Problem solving and taking initiative and driving to completion
• Strong understanding and experience of SDLC, support processes, and ticket management workflows
• Experience with Azure DevOps (ADO) for activity tracking and project management
• Experience gathering and documenting business requirements and process flows
• Experience working within Tier 1, 2, and 3 support models; Strong stakeholder management, communication, and facilitation skills
• Knowledge of clinical operations processes and GxP/regulatory environments is preferred
• Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps
• Strong analytical, troubleshooting, and problem-solving capabilities

Secondary Skills / Good to have In addition to core business analysis expertise, the candidate should bring secondary skills such as 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 HP ALM, and strong SQL and data analysis capabilities to support requirement validation and testing. 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 PM/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.