Clinical System Manager

Job Title: Clinical Systems Leader (Early Clinical Development)

Work Model: Hybrid (3 days onsite, 2 days remote)

Need Local Candidates to South San Francisco Only

Anchor Days: Tuesday to Thursday

Experience Level: Mid-level (2–5 years)

Function: Clinical Operations / Clinical Systems

Industry: Biopharmaceuticals / Clinical Research

We are looking for a Clinical Systems Leader (CSL) to own and drive the implementation of clinical systems supporting Early Clinical Development (ECD) studies. This role sits at the intersection of clinical operations, technology, and vendor management. You will lead system execution across studies, ensure regulatory compliance, and partner with cross-functional teams to deliver reliable, audit-ready clinical technology solutions.

This is a hands-on, accountability-heavy role. If you thrive in regulated environments, can manage vendors without hand-holding, and know how to translate protocol requirements into functional clinical systems, this role is for you.

Study Execution & System Ownership

• Lead implementation and lifecycle management of clinical systems including IxRS/IRT and eCOA for ECD studies
• Ensure systems align with study protocols, timelines, and operational needs

Project & Delivery Management

• Own end-to-end system build activities including requirements, specifications, UAT, deployment, maintenance, enhancements, and closeout
• Actively manage study-level timelines, dependencies, and deliverables

Technical Oversight & Compliance

• Ensure systems meet GCP, FDA regulations, industry best practices, and internal SOPs
• Maintain inspection-ready documentation across the system lifecycle

Cross-Functional Collaboration

• Partner with Clinical Trial Leaders, Biostatistics, Drug Supply Chain, Data Management, Procurement, and external vendors
• Operate independently with minimal oversight while staying tightly aligned with ECD and PET stakeholders
• Proactively identify, document, and resolve system risks and issues
• Drive mitigation plans with vendors and internal teams to closure

Communication & Stakeholder Management

• Communicate technical concepts clearly to non-technical stakeholders
• Present system updates, risks, and decisions to project teams and leadership with confidence

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, Information Systems, Data Science, or related field
• 2–5 years of experience in Clinical Operations or Clinical Systems Management
• 2–5 years of hands-on experience with IxRS/IRT and clinical trial systems
• Proven experience implementing systems such as IxRS/IRT, ePRO, and eCOA
• Strong working knowledge of GCP and FDA regulations governing clinical trials
• Demonstrated project management and vendor oversight experience
• Experience working in a regulated documentation environment
• Veeva experience is a plus

This role directly impacts trial execution quality, timelines, and compliance. You are not a passenger here. You are the system owner, the escalation point, and the execution driver. High visibility, real accountability, real impact.