Job Title: Clinical Systems Leader (CSL)
Location: South San Francisco, CA
Work Model: Hybrid (3 days onsite, 2 days remote)
Anchor Days: Tuesday Thursday
Interview Process: Two rounds (Virtual In-Person)
Role Overview
The Clinical Systems Leader (CSL) is responsible for the end-to-end implementation and management of clinical trial technology systems within Early Clinical Development. This role partners closely with cross-functional clinical teams and external technology vendors to ensure clinical systems such as IxRS/IRT and eCOA/ePRO are implemented, maintained, and compliant with regulatory and protocol requirements.
Key Responsibilities
Study Execution & System Management
Lead implementation and oversight of clinical systems including IxRS/IRT and eCOA/ePRO for assigned ECD studies
Ensure systems align with study protocols, timelines, and operational needs
Project & Lifecycle Management
Manage system build activities from requirements gathering through testing, deployment, maintenance, and study closeout
Own system specifications and documentation in a regulated environment
Technical & Regulatory Oversight
Ensure clinical systems comply with Google Cloud Platform, FDA regulations, industry standards, and internal SOPs
Review and approve system design, validation, and change management activities
Cross-Functional Collaboration
Partner with Clinical Trial Leaders, Biostatistics, Drug Supply Chain, Data Management, Procurement, and PET stakeholders
Coordinate with external technology vendors and vendor project managers
Issue & Risk Management
Proactively identify, document, and resolve system issues and risks
Implement mitigation strategies and ensure timely issue resolution
Communication & Leadership
Communicate technical and operational updates clearly to internal and external stakeholders
Prepare and deliver professional presentations to study teams and leadership
Required Qualifications
Bachelor's degree in Life Sciences, Computer Science, Engineering, Information Systems, Data Science, or related field
2 5 years of experience in Clinical Operations or Clinical Systems Management
2 5 years of hands-on experience with IxRS/IRT and clinical trial systems
Proven experience leading implementation of clinical systems (IxRS/IRT, eCOA, ePRO)
Strong knowledge of Google Cloud Platform and FDA regulations governing clinical trials
Excellent project management, documentation, and communication skills
Experience working in regulated environments
Familiarity with Veeva is a plus
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