Project Manager / Business Analyst with Clinical domain

Project Manager / Business Analyst with Clinical domain

Full-Time

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