Clinical Systems Leader

Clinical Systems Leader ROCGJP00039477

• Hourly pay: $60-$75/hr
• Worksite: Leading biotech company (South San Francisco, CA 94080 - Hybrid, Must be in office Tuesday through Thursday)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 12 Month Assignment

A leading biotech company is seeking a Clinical Systems Leader. The successful candidate will focus on system build, vendor selection, specification finalization, and providing UAT oversight.

Clinical Systems Leader Responsibilities:

• Implement all related clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD).
• 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.
• Technical Oversight: Provide technical oversight to ensure that clinical systems solutions adhere to the study protocol, industry regulations/best practices, and company policies, procedures, and guidelines.
• Issue and Risk Management: Proactively identify and track study-level technical issues to resolution.

Clinical Systems Leader Qualifications:

• 2-5 years of experience in Clinical Operations, or Clinical Systems Management.
• 2-5 years of IxRS/IRT and clinical-related systems experience.
• Bachelor's Degree in life science, computer science, engineering, information system, data science, or related discipline.
• Experience in Veeva is a plus.
• Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO, ERO, and eCOA.
• Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution.
• Strong project management skills to interpret protocols, define requirements, and oversee system builds with vendors.
• Familiar with documentation in a regulated environment.
• Experience in system setup, particularly with systems like Rave Medidata, and knowledge of integrating IXRS and EDC systems.
• Experience with UAT to provide oversight.
• Experience as a Clinical Data Manager or prior vendor-side experience is preferred.
• Experience with UAT.

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