Clinical Systems Leader (IRT/IxRT)

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

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.
  

• 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

[email protected]/[email protected]