Clinical Systems Leader; IRT​/IxRT

Clinical Systems Leader

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: $70- $75/hr on W2 Company Benefits:
Medical, Dental, Vision, Paid Sick leave, 401K Duration:
Long term contract (Possibility of further extension) Working Model:
Hybrid (three days in office, two remote) - Anchor Days are Tuesday through Thursday

NOTES: 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 requires experience with clinical systems and, ideally, with sponsor-side activities such as setting up systems and eCOA for clinical trial studies, specifically focusing on early phase studies (Phase 1 to 1B or
2). The position involves both system build and vendor management, where the candidate is expected to interpret study protocols, define requirements, work with vendors to build the system, and perform project and vendor management. 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.

Primary Responsibilities:

• 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. This includes 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.

Who You Are:

• 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 us your updated resume at  /