Clinical Systems Leader
Hybrid in San Francisco, CA, US • Posted 1 day ago • Updated 8 hours ago

Microgreen Technologies LLC
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Job Details
Skills
- Clinical Operations
- Clinical Systems Management
- IxRS
- IRT
- ePRO
- clinical systems
- clinical trials
- FDA
- regulations
- governing
Summary
Clinical Systems Leader
Duration: 12 Months
Location: South San Francisco, CA
Working Model: Hybrid (three days in office, two remote) - Anchor Days are Tuesday through Thursday
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
- Dice Id: 91109870
- Position Id: 8885147
- Posted 1 day ago
Company Info
A great team is the sum of its people. We are looking for those who want to make a difference with their talents and are looking to grow and learn EVERY.SINGLE.DAY.
Do you consider yourself an innovator? Do you measure each day by what you have accomplished? Read more.
From our business analysts who help identify the next opportunity to partner and addess a healthcare problem to our data visualization and AI/ML engineers who are adept with the latest technologies to our client support specialists who make sure that we are meeting and exceeding expectations, each team member is vital and we want to grow together. Collaboration, respect, and great work-life balance are key in our work culture.
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