IT R&D Business Analyst

We are seeking a highly motivated Business Analyst to support multiple R&D technology initiatives within a pharmaceutical environment. This individual will serve as an extension of the internal team, driving validation, requirements gathering, stakeholder coordination, and implementation activities across critical GxP-regulated systems.
The ideal candidate combines strong Computer System Validation (CSV) expertise with business analysis skills and can effectively partner with R&D stakeholders, statisticians, scientists, IT, IT Compliance, and external vendors. This person must be comfortable operating independently while managing multiple workstreams simultaneously.
Responsibilities
Computer System Validation (CSV)
• Lead and support validation activities for GxP-regulated systems and environments.
• Develop and review validation documentation, including:
o Requirements documentation
o Risk assessments
o Test scripts
o Validation plans and reports
o Standard operating procedures (SOPs)
• Coordinate and execute User Acceptance Testing (UAT).
• Ensure systems meet internal quality and compliance standards.
• Partner with vendors while independently managing internal validation requirements.
Business Analysis & Project Support
• Gather, document, and refine business and user requirements.
• Act as a liaison between business stakeholders, IT, IT Compliance, and external vendors.
• Facilitate stakeholder discussions and drive project deliverables to completion.
• Guide users through procedure development and testing activities.
• Track project actions, dependencies, and risks across multiple initiatives.

Payrate - $70-75/hr

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• 5+ years of business analyst experience working within the Life Science domain
o Experience supporting clinical research, clinical development, or scientific organizations.
• Computer System Validation (CSV) experience within regulated environments.
• Strong understanding of the Software Development Lifecycle (SDLC) and validation methodologies.
• Experience creating requirements, test scripts, validation documentation, SOPs, and UAT materials.
• Familiarity working alongside scientists, clinical teams, or statisticians.
• Understanding of regulatory requirements impacting clinical data and validated systems.

• Experience supporting clinical trial data environments.
• Knowledge of clinical data management processes.
• Exposure to Clinical Pharmacology organizations or workflows.
• Experience supporting Biostatistics teams.
• Familiarity with SAS, R, or Python-based research environments.
• Understanding of how statistical outputs support regulatory submissions.
• Experience working with vendor-hosted systems and cloud-based platforms.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.