Description

Bridge the gap between business needs and technical solutions in a pharmaceutical research environment. You will own the translation of R&D and Enterprise Operations requirements into functional specifications and user stories.

Responsibilities

• Gather and analyze complex requirements for R&D projects, translating them into clear functional and non-functional requirements.
• Design technology solutions with Enterprise Architects to ensure integration with existing landscapes and compliance with GxP and FDA 21 CFR Part 11.
• Execute the Computer Systems Validation (CSV) process, including creating and executing test plans to verify system efficacy.
• Facilitate communication between stakeholders and IT professionals to align on project scope, timelines, and technical requirements.
• Support the project lifecycle from initial concept through post-implementation maintenance, including bug-fix planning and process improvements.

Required Skills

• 7+ years of experience as a Business System Analyst.
• Strong background in clinical research, GxP, and CSV environments.
• Deep understanding of the Clinical Drug Development Lifecycle.
• Experience managing data pipelines and gathering complex data requirements.
• Proficiency with SDLC, Agile, Scrum, and Waterfall methodologies.
• Knowledge of SaaS, PaaS, and IaaS models.
• Experience working with AWS or Azure environments.
• Familiarity with CROs/FSPs.
• Ability to model business and IT processes and manage project scopes.

Key Skills

Education

Any Gradute