Job Description

Clinical System Analyst

W2 Contract

Location: Redwood City, CA - Hybrid Role

Duties and Responsibilities:

• Dashboard Support: Assist in developing and maintaining various dashboards for data review, analysis, performance metrics, and operational insights for Biostatistics, Clinical Data Science, Clinical Systems, Medical Science, and Statistical Programming.
• Software Validation: Collaborate with Clinical Operations to evaluate and implement GxP-compliant clinical systems (e.g., CTMS) to ensure data integrity. Collect requirements from stakeholders and work closely with IT to prepare IQ, OQ, PQ, and UAT test cases.
• System Management and Maintenance: Support the controlled clinical analysis systems for Statistical Programming to ensure system availability, performance, and compliance. Prepare and organize documentation for folder access control, system patches, and changes.
• Training Material: Prepare and organize onboarding materials, including guides, video clips, and knowledge bases, for various clinical systems, ensuring they are posted with a user-friendly UI/UX design for accessibility.
• Automation: Develop lightweight utility tools for automation to support system management and data processing. Manage documents and program scripts with version control systems.
• Teamwork: Participate in team meetings with Statistical Programming, Biostatistics, Clinical Data Science, Clinical Operations, Medical Science, and IT to improve system management, training delivery, dashboards, and GxP validation processes across multiple priorities.

Requirements and Qualifications:

• Bachelor's degree in Computer Science, Health Informatics, or a related field (or equivalent front-end programming experience)
• Basic knowledge of dashboard tools (e.g., Python, Power BI) and supporting system performance reporting
• Familiarity with creating training materials and understanding of UI/UX principles and software (e.g., Davinci) to ensure user-friendly delivery.
• Experience managing and maintaining clinical systems (e.g., CTMS) in a GxP-regulated environment, with the ability to thrive in a fast-paced setting.
• Understanding of the software development life cycle and validation processes (IQ, OQ, PQ, and UAT) and interpreting requirements and specifications, with strong attention to detail
• Experience with version control systems (e.g., Git) to track documentation changes in a GxP-compliant manner across multiple projects.
• Eagerness to adapt to new programming languages, tools, and technologies under dynamic conditions
• Exceptional problem-solving skills and meticulous attention to detail, focusing on data integrity, traceability, and patient safety in GxP systems
• Ability to handle multiple projects simultaneously, work effectively in a team, and communicate technical and regulatory concepts across diverse departments, including IT, in a fast-paced environment.
• Managing deadlines with meticulous attention to detail across concurrent tasks.

Preferred Qualifications:

• Hands-on experience managing GxP-compliant clinical systems in a pharmaceutical setting.
• Practical experience with UI/UX tools or platforms for organizing GxP-compliant training content under tight deadlines.
• Familiarity with maintaining dashboards for clinical or operational insights in a GxP-regulated environment.
• Experience supporting validation or testing of GxP-compliant clinical systems with precision.
• Exposure to documentation platforms (e.g., Confluence) or clinical system validation

Desired Skills and Experience

Clinical analysis systems, Python, Power BI, UI/UX, Davinci, CTMS, SDLC, UAT, Git, GxP-compliant, Confluence, dashboards, software validation, system management, statistical programming, automation, training material

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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