This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Seeking a Clinical Systems Leader for a contract opportunity in South San Francisco, CA. The position, which is not a people management role, is part of the four-person clinical system function within the Clinical Insights Group and focuses on system build, vendor selection, specification finalization, and providing UAT oversight.
Job Responsibility:
System build
Vendor selection
Specification finalization
Providing UAT oversight
Interpret study protocols, define requirements, work with vendors to build the system
Perform project and vendor management
Vendor selection based on study requirements
Leading the finalization of system specifications
Providing oversight of the study build
Managing system issues with vendor support
Providing oversight and project management of the study with vendors
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
Expertise in clinical systems (especially IXRS and eCOA for early-phase studies)
Strong project and vendor management skills to interpret protocols, define requirements, and oversee system builds with vendors
Minimum of two to three years of relevant experience