Clinical Systems Leader; IRT​/IxRT

Job Title:

Clinical Systems Leader – Early Clinical Development

Our client, a world leader in biotechnology and life sciences, is looking for a Clinical Systems Leader based out of South San Francisco, CA (Hybrid).

• Job Duration:
  Long Term Contract (Possibility of Extension)
• Pay Rate: $48/hr on W2
• Benefits:
  Medical, Dental, Vision, Paid Sick Leave, 401K
• Working Model:
  Hybrid (three days in office, two remote – Anchor Days Tuesday through Thursday)

HM clarified that this role requires expertise in clinical systems (especially IXRS and eCOA for early-phase studies) and strong project and vendor management skills to interpret protocols, define requirements, and oversee system builds with vendors. The position 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.

The role involves both system build and vendor management, interpreting study protocols, defining requirements, working with vendors to build the system, and performing project and vendor management.

• Study Execution and System 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.
• Project Management:
  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, including requirements review, testing, deployment, maintenance, enhancement, and closeout.
• Technical Oversight:
  Provide technical oversight to ensure that clinical systems solutions (e.g., IxRS/eCOA) adhere to the study protocol, industry regulations/best practices, and company policies, procedures, and guidelines.

• 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.
• Familiar with documentation in a regulated environment; experience in Veeva is a plus.

If interested, please send your updated resume to  or