Jobs · Business Development · California

Business Analyst- Risk-based quality management (RBQM)

Falcon Smart IT (FalconSmartIT) · San Jose, CA · 3 wk ago
On-siteBusiness DevelopmentFull-time

Job Description

Minimum 10 yrs

Primary skills

  • 8+ years of experience in Business Analysis, Clinical Systems Support, or Clinical Operations Technology.
  • Must understand GXP system validation process
  • Must be familiar with AWS environments.
  • Working understanding of risk-based quality management (RBQM)
  • Experience working with statisticians and Clinical Operations risk managers
  • Basic SQL skills for data analysis and data verification.
  • Basic Python skills for data analysis.
  • Knowledge of clinical operations processes and GxP/regulatory environments is preferred.

Educational Qualification

Any Bachelor's Degree

Experience Range

10+ Years

Tagline/Tech Stack Snapshot - BA Experience

BA Experience

Role Summary

We are seeking a Business Analyst with requirement gathering, documentation, and stakeholder engagement within the clinical domain.

Primary (Must have skills)

  • 8+ years of experience in Business Analysis, Clinical Systems Support, or Clinical Operations Technology.
  • Must understand GXP system validation process
  • Must be familiar with AWS environments.
  • Working understanding of risk-based quality management (RBQM)
  • Experience working with statisticians and Clinical Operations risk managers
  • Basic SQL skills for data analysis and data verification.
  • Basic Python skills for data analysis
  • Must be able to quickly learn to use new systems
  • Strong stakeholder management, communication, and facilitation skills.
  • Experience gathering and documenting business requirements and process flows.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Strong analytical, troubleshooting, and problem-solving capabilities.
  • Experience working within Tier 1, 2, and 3 support models.
  • Knowledge of clinical operations processes and GxP/regulatory environments is preferred.
  • Strong, clear, concise written and oral communication
  • Ability to self-motivate and work independently
  • Provides proactive status updates
  • Experience working for pharmaceutical company in development

Why This Role Matters

This position is critical for customer who can able to independently handled all BA experience at Offshore

What You'll Do/Job Description of Role

We are seeking a Business Analyst with requirement gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analysing and translating business needs into BRDs, user stories, and acceptance criteria, while collaborating closely with development, QA/UAT, and project management teams to ensure successful delivery.

Soft skills/other skills

Communication Skills: Communicate effectively with internal and customer stakeholders Communication approach: verbal, emails and instant messages Interpersonal Skills: Strong interpersonal skills to build and maintain productive relationships with team members Provide constructive feedback during code reviews and be open to receiving feedback on your own code. Problem-Solving and Analytical Thinking: Capability to troubleshoot and resolve issues efficiently. Analytical mindset Task/ Work Updates Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps Provides regular updates, proactive and due diligent to carry out responsibilities

What Success Looks Like (6–12 Months)

Expected Outcome The Business Analyst will ensure that business requirements are clearly understood, documented, and translated into actionable deliverables, leading to the successful implementation of clinical systems and processes. The role is expected to drive alignment between stakeholders, technical teams, and project managers, ensuring that all solutions meet business objectives, comply with industry standards, and are delivered on time with high quality.

Why Join Us

To be part of one of the most important engagements for our customer, supporting Business Process Owners and Project Managers to define, document, and deliver complex business and system requirements for the RBQM data pipeline

About FalconSmartIT

We are a specialist IT Recruitment Agency. We specialise in finding the best IT professionals for your given IT requirement.

Falcon Smart LLC (US), Falcon Smart IT (UK), FS Talent Acquisition (India) set a mission to deliver value, service, transparency and quality service to all.

Headquartered in London,UK

We are Specialists at providing contract and permanent IT, Marketing, HR and Accountancy recruitment across the Globe, working with businesses of all sizes, from Small to Medium Enterprises (SMEs) to large international corporations.

Our industry and sector knowledge is second to none and whilst we utilise all of the key IT specific and leading generic job boards, nothing compares to our own carefully grown database and working knowledge of “whose who” in key industry sectors.

In short there is no need to look anywhere else for your IT staffing needs. But don’t just take our word for it. Here’s what some of our current clients say. So why not give us a call on +4402039839238, We’re looking forward to working with you.

US Tel : +00 1 3025252515

UK Tel : +00 44 02039839238

India Tel : +91 9629812116

Email: info@falconsmartit.com

www.falconsmartit.com

8 The Green, Dover, DE 19901, USA

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