Clinical Systems Leader (CSL) - South San Francisco, CA (Hybrid 3days/week)

Hi.

Please find the below JD and share your updated resume

Position - Clinical Systems Leader (CSL)
Location: South San Francisco, CA (Hybrid 3days/week)

Interview: 2 rounds (Virtual + In-person)

Role Overview

The Clinical Systems Leader (CSL) manages implementation and maintenance of clinical trial technology systems within Early Clinical Development. This role collaborates with cross-functional teams and vendors to ensure compliant, efficient clinical system delivery.

Key Responsibilities

• Implement and manage clinical systems (IxRS/IRT, eCOA, ePRO) for study execution
• Lead end-to-end system build lifecycle: requirements, testing, deployment, maintenance, and closeout
• Ensure compliance with study protocols, Google Cloud Platform, FDA regulations, and company standards
• Coordinate with stakeholders (Clinical, Biostatistics, Supply Chain, Data Management, Vendors)
• Track and resolve technical issues, risks, and mitigation plans
• Provide strong communication, reporting, and presentations to stakeholders

Required Qualifications

• Bachelor s degree in Life Science, CS, Engineering, IS, or related
• 2 5 years in Clinical Operations or Clinical Systems Management
• 2 5 years experience with IxRS/IRT and clinical systems
• Proven experience implementing clinical trial systems
• Knowledge of Google Cloud Platform, FDA regulations, and regulated documentation
• Strong project management and communication skills
• Veeva experience plus

Best Regards,