Clinical Systems Leader

Clinical Systems Leader ROCGJP00039291

• Hourly pay: $40-$45/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 be responsible for implementing all related clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD).

Clinical Systems Leader 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.
• 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, and eCOA.
• Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution.
• Excellent written and verbal communication skills and strong project management skills.
• Familiar with documentation in a regulated environment.

(H)