Business Analyst (Clinical Systems)

BrezQ; Foster City (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

BrezQ in Foster City, CA, is seeking a seasoned Business Analyst / Project Manager to bridge business strategy, clinical operations and technical execution for Clinical Systems.

You will lead end-to-end requirements, manage delivery in Agile, and provide Tier-1/3 support for CTMS and RBQM. You’ll coordinate with Study Managers, QA/UAT and Dev teams to ensure compliant, on-time deployments that empower clinical teams to meet their goals.

Qualifications

• 8+ years of BA/PM experience in Clinical Systems.
• Expertise in CTMS, RBQM, or clinical portfolio support.
• Experience with Agile/Scrum and delivery tracking in Azure DevOps (ADO) or Jira.
• Understanding SDLC, support processes, and ticket workflows.
• Experience in Tier 1/2/3 support models.
• Strong communication and facilitation for workshops and requirements gatherings.

Responsibilities

• Coordinate project scopes, timelines, risks, and deliverables with cross-functional teams.
• Gather, analyze, and translate business needs into BRDs and user stories.
• Provide day-to-day Tier 1/2/3 support for clinical applications; manage tickets.
• Collaborate with Study Managers, QA/UAT, and Development to define tasks and estimates.
• Conduct user training and knowledge transfer for system adoption.

Skills

BA/PM experience

Clinical domain knowledge

Agile/Scrum

Azure DevOps

SQL & data analysis

Communication & facilitation

SDLC knowledge

Tools

Azure DevOps

Jira

MS Visio

Job description

Business Analyst / Project Manager (Clinical Systems)

Location: Foster City, CA 94404

Job Type: Full-Time | Direct-Hire

About the Role

We are looking for an experienced Business Analyst / Project Manager with strong Clinical Domain expertise to bridge the gap between business strategy, clinical operations, and technical execution.

In this dual-capability role, you will lead end-to-end requirement management, oversee project delivery using Agile frameworks, and provide operational tier-support for critical Clinical Systems (such as CTMS and RBQM). You will be a key liaison across cross-functional teams, ensuring solutions align with business goals, GxP compliance standards, and regulatory guidelines.

Key Responsibilities

• Project Management & Stakeholder Alignment: Coordinate and facilitate discussions across Clinical Systems and Operations to align on project scopes, timelines, risks, and deliverables. Track integrated timelines and manage project backlogs using Azure DevOps (ADO).
• Requirements & Documentation: Gather, analyze, and translate business needs into detailed BRDs, user stories, use cases, and acceptance criteria. Develop process flows, SOPs, and user training materials.
• Tiered Application Support: Provide day-to-day Tier 1, 2, and 3 support for custom and SaaS clinical applications. Manage support tickets, perform functional troubleshooting, and resolve business issues within defined SLA timelines.
• Cross-Functional Collaboration: Partner closely with Study Managers, Business Leads, QA/UAT, and Development teams to define technical tasks, estimate resources, and facilitate smooth solution delivery.
• Enablement & Training: Conduct user training and knowledge transfer sessions to support organizational readiness and smooth system adoption.

Qualifications & Experience

• Clinical Domain Expertise: 8+ years of combined BA/PM experience with deep knowledge of Clinical Systems, Clinical Trial Management Systems (CTMS), Risk-Based Quality Management (RBQM), or Clinical Portfolio Support.
• Technical & Methodological Skills:
• Hands‑on experience with Agile/Scrum methodologies and delivery tracking in Azure DevOps (ADO) or Jira.
• Strong understanding of full Software Development Life Cycle (SDLC), support processes, and ticket management workflows.
• Experience supporting applications in a Tier 1/2/3 support model.
• Communication & Facilitation: Proven track record of leading workshops, requirement gathering sessions, and managing stakeholder expectations in a fast‑paced environment.

Nice to Have (Secondary Skills)

• Knowledge of regulatory frameworks and compliance standards (e.g., 21 CFR Part 11, GxP compliance).
• Practical SQL and data analysis skills for validating requirements, reporting, and supporting UAT.
• Proficiency in documentation and visualization tools (MS Visio, MS Project, Excel, PowerPoint).

What Success Looks Like

You will successfully drive clinical system implementations from concept to deployment. By producing crisp business documentation, maintaining clear visibility into timelines, and resolving operational support issues efficiently, you will ensure our clinical systems operate seamlessly, remain compliant, and empower our clinical teams to hit their goals on time.