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Clinical Systems Leader

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Revel IT

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Location:
United States , South San Francisco

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Contract Type:
Not provided

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Salary:

Not provided

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

Additional Information:

Job Posted:
January 24, 2026

Work Type:
Hybrid work
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