RBQM Business Analyst — Clinical Data & Validation

Falcon Smart IT (FalconSmartIT); San Jose (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

Falcon Smart IT (FalconSmartIT) is looking for a Business Analyst specializing in risk-based quality management (RBQM) in San Jose, CA. The position requires extensive experience in business analysis, particularly within clinical systems and operations, with a focus on requirement gathering and stakeholder engagement.

The ideal candidate should have a strong understanding of GXP validation and AWS environments, as well as skills in SQL for data analysis. Key responsibilities include leading requirements refinement and user acceptance testing while ensuring the timely delivery of high-quality solutions.

Qualifications

• 8+ years of experience in Business Analysis, Clinical Systems Support, or Clinical Operations Technology.
• Must understand GXP system validation process.
• Experience Required: 10+ years in relevant fields.

Responsibilities

• Partner with Business Process Owners and Project Managers for requirements documentation.
• Lead requirements refinement and stakeholder alignment.
• Own User Acceptance Testing planning and execution.

Skills

Business Analysis

GXP system validation

AWS environments

Risk-based quality management (RBQM)

Basic SQL skills

Clinical operations processes

Education

Bachelor's Degree

Tools

Jira

Azure DevOps

Job description

Falcon Smart IT (FalconSmartIT) is looking for a Business Analyst specializing in risk-based quality management (RBQM) in San Jose, CA. The position requires extensive experience in business analysis, particularly within clinical systems and operations, with a focus on requirement gathering and stakeholder engagement.

The ideal candidate should have a strong understanding of GXP validation and AWS environments, as well as skills in SQL for data analysis. Key responsibilities include leading requirements refinement and user acceptance testing while ensuring the timely delivery of high-quality solutions.