Business Analyst (RBQM & Clinical Domain)

We're Hiring | Business Analyst (RBQM & Clinical Domain)

Location: Foster City, CA (Remote)
Employment Type: Full-Time (FTE)
Experience Required: 10+ Years
Education: Bachelor's Degree

We are seeking an experienced Business Analyst with strong expertise in Clinical Operations, RBQM (Risk-Based Quality Management), and Pharmaceutical Development to support a critical clinical data pipeline initiative.

Role Overview

As a key contributor, you will partner with Business Process Owners, Project Managers, Clinical Operations teams, and technical stakeholders to define, document, and deliver complex business and system requirements supporting the RBQM data pipeline.

Key Responsibilities

Lead requirements gathering, analysis, and documentation

Conduct:

• Current State Analysis
• Future State Analysis
• Process Mapping
• Requirements Prioritization

Create and refine:

• Business Requirement Documents (BRDs)
• Functional Requirements
• User Stories
• Acceptance Criteria

Drive stakeholder alignment across business and technical teams

Own and lead:

• User Acceptance Testing (UAT) Planning
• UAT Execution
• Defect Validation
• Release Readiness Activities

Partner with Validation teams to ensure testability and compliance

Support Agile/Scrum delivery teams and participate in project planning activities

Required Skills

8+ years of Business Analysis experience

Experience in:

• Clinical Systems Support
• Clinical Operations Technology
• Pharmaceutical/Life Sciences Industry

Strong understanding of:

• GxP / GXP Validation Processes
• Clinical Operations Workflows
• Regulatory Compliance Environments

Familiarity with AWS environments

Strong stakeholder management and communication skills

Experience with:

• Requirements Gathering
• Process Documentation
• Tier 1 / Tier 2 / Tier 3 Support Models
• Agile/Scrum Methodologies
• Jira / Azure DevOps

Ability to work independently and manage multiple priorities

Preferred Skills

Working knowledge of Risk-Based Quality Management (RBQM)

Experience collaborating with:

• Clinical Operations Risk Managers
• Statisticians

Basic SQL skills for data analysis and validation

Basic Python skills for data analysis

Why Join Us?

This is a high-visibility engagement supporting a strategic RBQM initiative within the clinical domain. You'll play a critical role in driving business and technical alignment while contributing to the successful delivery of enterprise clinical solutions.

Interested candidates, please share:
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