Job Title : Clinical Systems Leader
Duration : 1+yr contract
Location : South San Francisco CA
***Working Model: Hybrid (three days in office, two remote) - Anchor Days are Tuesday through Thursday
Interview Format: Two rounds (1 - virtual; 2 in-person)***
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.
- 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. Works 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.
Who You Are:
- 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
- Excellent written and verbal communication skills and strong project management skills
- Familiar with documentation in a regulated environment. Experience in Veeva is a plus
All your information will be kept confidential according to EEO guidelines.
