Clinical Systems Leader

Overview

Clinical Systems Leader ROCGJP

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

• 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.

• 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.