Clinical Systems Leader – hybrid Revel IT

OUR GOAL: Treat our consultants and clients the way we would like others to treat us! Interested in joining our team? Check out the opportunity below and apply today!

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.

Expertise in clinical systems (especially IXRS and eCOA for early-phase studies) and strong project and vendor management skills are required to interpret protocols, define requirements, and oversee system builds with vendors. Preferred candidates should have a bachelor’s or science degree, a minimum of two to three years of relevant experience, and ideally some background as a clinical data manager or prior vendor-side experience.

Working Model: Hybrid (three days in office, two remote) – Anchor Days are Tuesday through Thursday.

• 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 team has current internal standard templates, but the candidate must also be knowledgeable about customization during the build process.
• Daily responsibilities for the first 30 to 60 days include 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.
• The candidate is expected to have experience with UAT to provide oversight, although external partners currently perform the actual testing.
• Team Structure and Reporting:
  The role is not a people management position but focuses on providing oversight and project management of the study with vendors. The clinical system function currently consists of four people, supporting early-phase studies within the broader 15-person Clinical Insights Group. Although the current role is not permanent, a conversion from a contractor position has happened previously, suggesting a future possibility.
• Study Focus and Vendor
  
  Experience:
  
  Most studies involve drug testing, with occasional device-related studies, justifying the need for eCOA or ERO knowledge. The team seeks experience in system setup, particularly with systems like Rave Medidata, and knowledge of integrating IXRS and EDC systems. Experience working on the vendor side is highly valued, as it provides a strong understanding of system-side operations and sponsor needs.

• The top three skills sought are knowledge of IXRS and eCOA systems, strong project management, and vendor management experience, along with general industry experience working with clinical trial studies.
• Clinical data managers with experience in eCOA and IXRS systems could be a good fit.
• The ideal candidate should have a minimum of two to three years of experience, but more experienced individuals will be considered, acknowledging that compensation rates might be a factor.
• Technical and Educational Background:
  The role is described as more technical than a traditional clinical trial manager position, focusing on system building, and is titled ‘clinical systems leader’.
• A bachelor’s or science degree in life science, data science, or computer/system-related field is preferred.
• The team is looking for someone who can manage a study independently with minimum training, although they are open to training those with slight knowledge gaps in business processes.

• 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
• Su…