Business Analyst

Position Summary The Senior Business Analyst will play a key role in driving business requirements, user story development, and reporting/visualization capabilities in support of DevTech products. This role partners closely with clinical, data, and technology teams to deliver compliant, high-quality solutions aligned with industry standards, Quality Management Systems, and regulatory expectations. Key Responsibilities • Lead planning, business requirements gathering, and user story development for reporting and visualization needs. • Author and refine system support documentation, including process flows, configurations, and interdependency mappings. • Work with clinical scientific data and data systems, with a strong understanding of clinical data management activities. • Collaborate with Testing teams to create and review User Acceptance Testing (UAT) scripts and manage the end-to-end UAT lifecycle through product release. • Translate business requirements into detailed user stories and functional specifications for Agile development teams. • Ensure compliance with regulatory requirements, including 21 CFR Part 11, GxP, and IT infrastructure controls. • Identify potential risks proactively and drive timely resolution. • Adhere to company Quality Management Systems, Software Development Life Cycle (SDLC), and Project Life Cycle standards. • Work independently with stakeholders to prioritize requirements and act as a primary resource on complex issues. • Build relationships across cross-functional teams, analyze issues, and contribute to solution development. • Maintain strong partnerships with key business stakeholders. Functional Requirements • Bachelor’s degree in a science discipline or related field (or equivalent). • 7–10 years of pharmaceutical or related industry experience implementing clinical solutions. • Strong knowledge of clinical data management processes, data review, and data visualization tools. • Proficient understanding of Quality Assurance/Compliance, GxP regulations, and 21 CFR Part 11. • Experience working within an SDLC framework (delivery, testing, software QA, change management). • Hands-on experience with Agile tools such as JIRA and Confluence. • Ability to clearly articulate complex technical issues and solutions to business stakeholders. • Excellent written and verbal communication skills, including presentation capabilities. • Proven ability to identify operational gaps and implement corrective action plans. Preferred Qualifications • Experience in the Pharma and/or Biotech industry. • Working knowledge of clinical data systems such as EDC, Clinical Data Management platforms, and clinical data flow. • Familiarity with data review and visualization tools (e.g., Veeva CDB, JReview). • Experience working with global teams remotely. • Understanding of change control and SDLC processes related to computer system validation.