Clinical Systems Leader

Overview

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• 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.
• 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.
• Collaboration and Teamwork:
  Work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Trial Leader, Biostatistician, Drug Supply Chain, Data Management functions, and Procurement) and technology vendors. Work independently with PET stakeholders and/or cross-functional project teams with little to no oversight. Work collaboratively with the ECD I&A team to share knowledge.
• Issue and
  
  Risk Management:
  
  Proactively identify and track study-level technical issues to resolution. Ensure prompt resolution of system issues, document issues and risks, and implement mitigation plans in partnership with the study team and technology vendor project manager.
• Communication & Presentation
  
  Skills:
  
  Strong verbal and written communication skills; strong business presentation skills; able to explain technical issues and communicate clearly, concisely, and professionally with internal, external stakeholders and departmental leadership.

• Bachelor's Degree in life science, computer science, engineering, information systems, 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
• Excellent written and verbal communication skills and strong project management skills
• Familiar with documentation in a regulated environment. Experience in Veeva is a plus