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Clinical Systems Leader

United States, South San Francisco · Job Posted January 24, 2026
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Job Description

The Clinical Systems Leader (CSL) is responsible for implementing all related clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD). The CSL collaborates with a cross-functional team of internal stakeholders and technology vendors to ensure the successful implementation and maintenance of technology solutions supporting clinical trials.

Job Responsibility

  • Implement all related clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD)
  • Collaborate with a cross-functional team of internal stakeholders and technology vendors to ensure the successful implementation and maintenance of technology solutions supporting clinical trials
  • Focus on system build, vendor selection, specification finalization, and providing UAT oversight
  • Interpret study protocols, define requirements, work with vendors to build the system, and perform project and vendor management
  • Accountable for implementing all related clinical systems, such as Interactive Response Technologies (IxRS) and electronic Clinical Outcome Assessments (eCOA) actions for the ECD portfolio
  • Closely manage study-related timelines and associated activities
  • Manage and lead the end-to-end specifications for the build of clinical systems for an assigned study or enterprise project
  • Provide technical oversight to ensure that clinical systems solutions adhere to the study protocol, industry regulations/best practices, and company policies, procedures, and guidelines
  • Work with a cross-functional team of internal stakeholders and technology vendors
  • Proactively identify and track study-level technical issues to resolution
  • Ensure prompt resolution of system issues, document issues and risks, and implement mitigation plans in partnership with the study team and technology vendor project manager
  • Vendor selection based on study requirements, leading the finalization of system specifications, providing oversight of the study build, and managing system issues with vendor support
  • Provide oversight of UAT

Requirements

  • Bachelor’s Degree in life science, computer science, engineering, information system, data science or related discipline
  • 2-5 years of experience in Clinical Operations, or Clinical Systems Management
  • 2-5 years of IxRS/IRT and clinical-related systems experience
  • Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO, and eCOA
  • Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
  • Excellent written and verbal communication skills and strong project management skills
  • Familiar with documentation in a regulated environment

Nice to have

  • Experience in Veeva is a plus
  • Some background as a clinical data manager or prior vendor-side experience

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