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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