Business Analyst – Clinical Trial Experience

Business Analyst – Clinical Trial Experience

Experience: 8–10 Years

Location: Bengaluru

Domain: Clinical Research / Pharma IT

Role Summary

The Business Analyst will act as a strategic liaison between Clinical Operations and Technology teams, enabling efficient and innovative execution of clinical trials. This role supports key capabilities including Clinical Automation, Trial Accessibility, and Scientific Trial Design, while ensuring compliance with regulatory standards.

Key Responsibilities

• Collaborate closely with clinical stakeholders to gather, analyze, and document business and functional requirements.
• Translate clinical and operational needs into clear specifications for technology and delivery teams.
• Support capability design, product roadmap planning, and backlog management in an Agile environment.
• Participate in sprint planning, reviews, and requirement prioritization.
• Write, review, and validate test scripts, user acceptance criteria, and training materials.
• Support User Acceptance Testing (UAT) and ensure traceability from requirements to testing.
• Advocate and drive digitization, automation, and technical innovation in clinical trial processes.
• Ensure solutions align with regulatory, quality, and compliance standards (e.g., GxP, 21 CFR Part 11).
• Act as a key point of contact between business, clinical, and IT teams to ensure successful delivery.

Required Qualifications

• Bachelor’s degree in Life Sciences, Information Technology, or a related field.
• 7+ years of experience in the clinical trials or pharmaceutical domain, with strong exposure to clinical systems and processes.
• Proven experience as a Business Analyst in Pharma IT or Clinical Research environments.
• Strong communication, documentation, and stakeholder management skills.
• Hands-on experience with Agile methodologies and tools such as JIRA and Visio.
• Good understanding of clinical trial lifecycle, clinical operations, and regulatory requirements.

Preferred Skills

• Experience working on clinical trial systems such as CTMS, EDC, eTMF, or related platforms.
• Exposure to digital transformation or automation initiatives in clinical research.
• Ability to work in cross-functional, global teams.