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Job description
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Advanced Software Talent, is hiring for a Clinical Systems Leader (CSL). Applicants should be local San Francisco Bay Area residents. No third‑party agencies will be considered; only direct W2 contractors are eligible.
The CSL is responsible for implementing all clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD). The role 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), for the ECD portfolio.
Project Management – Closely manage study‑related timelines and activities; lead end‑to‑end specifications for building clinical systems for assigned studies or enterprise projects, including requirements review, testing, deployment, maintenance, enhancement, and closeout.
Technical Oversight – Provide oversight to ensure clinical system solutions (e.g., IxRS/eCOA) adhere to study protocols, industry regulations, best practices, and company policies.
Collaboration and Teamwork – Work with cross‑functional internal stakeholders (Clinical Trial Leader, Biostatistician, Drug Supply Chain, Data Management, Procurement) and technology vendors; independently manage projects with minimal oversight; collaborate with the ECD I&A team to share knowledge.
Issue and Risk Management – Proactively identify and track study‑level technical issues, ensure prompt resolution, document issues and risks, and implement mitigation plans in partnership with study teams and vendors.
Communication & Presentation – Strong verbal and written communication skills; effective business presentation skills; ability to explain technical issues clearly, concisely, and professionally to internal, external stakeholders and leadership.
Skills Required
Bachelor’s Degree in life science, computer science, engineering, information systems, data science, or a related discipline.
2–5 years of experience in Clinical Operations or Clinical Systems Management.
2–5 years of experience with IxRS/IRT and related clinical systems.
Successful track record in implementing clinical systems such as IxRS/IRT, ePRO, and eCOA.
Working knowledge of Good Clinical Practice (GCP) and FDA regulations governing clinical trial execution.
Excellent written, verbal, and project management communication skills.
Familiarity with documentation in a regulated environment; experience with Veeva is a plus.
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Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.