Job description

Position Clinical Systems Leader

Location South San Francisco CA

Duration Long Term Contract

Client Genentech

Summary

The Clinical Systems Leader (CSL) role sits within the gRED Early Clinical Development Informatics (ECDi) Systems Operations (Sys Ops) Team. The CSL ensures that clinical systems are appropriately setup and operational for Genentech’s Early Clinical Development (ECD) Trials. The CSL interfaces with Protocol Execution Teams (PETs) and other internal stakeholders, serving as the primary point of contact for clinical systems at the

individual study or project level. The CSL has expertise in Systems Development Lifecycle (SDLC), Business Systems Analysis, Project Management, and Vendor Management.

Job Responsibilities

• Accountable to and partners with PET members including Clinical Operations, Biostatistics, Clinical Supplies, Data Management, and Vendor PMs, to deliver high quality and efficiently designed systems.
• Manages the end-to-end specifications for the build of outsourced clinical trial systems needed for a given study, including requirements review, testing, deployment, maintenance, and enhancements.
• Manages and executes UAT processes for various systems, including test case generation, defect management and resolution
• Serves as a crucial stakeholder for systems support requests for clinical studies.
• Assesses the needs of the PET continually, and proactively finds and recommends system solutions.
• Ensures prompt resolution of system issues and provides timely and accurate root cause analysis, escalation, and issue tracking support.
• Gathers, receives and interprets requirements from end users and documents business requirements.
• Monitors key performance indicators (KPIs) and conducts qualitative analyses to identify root causes for defects and recommends process improvements.
• Identifies process inefficiencies and compliance gaps and participates in process improvement initiatives.
• Acts as a subject matter expert for Sys Ops supported systems.
• Develops strong relationships and maintains effective communication with Clinical Operations, Clinical Science, and other functional departments.

Job Types: Full-time, Contract

Pay: $55.00 - $58.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• South San Francisco, CA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Clinical Development Informatics: 2 years (Required)
• clinical trial: 4 years (Required)
• Data Management: 4 years (Required)
• GxP: 3 years (Required)

Work Location: One location

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