Senior Clinical Trials IT Business Analyst in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Clinical Trials IT Business Analyst in the United States.

This role acts as a key bridge between clinical operations and information technology, driving the design, implementation, and optimization of digital solutions that support global clinical trial activities. You will translate complex clinical and scientific requirements into functional system specifications and scalable technical solutions that enhance research efficiency and data integrity. Working in a highly regulated, GxP-compliant environment, you will contribute to the full lifecycle of clinical systems, from analysis and design through validation, deployment, and continuous improvement. The position involves close collaboration with cross-functional teams, vendors, and clinical stakeholders to ensure systems meet operational and regulatory expectations. You will also play a critical role in ensuring data accuracy, system integration, and compliance with global standards. This is a strategic and highly technical role ideal for someone passionate about clinical research innovation and enterprise systems in healthcare.

• Gather, analyze, and document detailed business, functional, and technical requirements, translating clinical needs into system specifications and scalable solutions.
• Develop key documentation including Business Requirements Documents (BRDs), user stories, functional specifications, process flows, and data flow diagrams.
• Lead or support implementation, enhancement, and lifecycle management of clinical systems such as LIMS, LIS, ELM, and related platforms.
• Oversee system validation activities (CSV/CSA), including test planning, IQ/OQ/PQ documentation, and regulatory compliance alignment.
• Lead User Acceptance Testing (UAT), coordinate defect tracking, and support deployment, regression testing, and post-go-live stabilization.
• Collaborate with IT, vendors, and clinical stakeholders to ensure successful system integration, data governance, and reporting capabilities.

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or a related field.
• Minimum of 3 years of experience in clinical research, clinical IT systems, or regulated GxP environments.
• Strong background in business analysis, requirements gathering, and systems documentation.
• Experience working with clinical or laboratory systems such as LIMS/LIS (e.g., STARLIMS) and enterprise clinical platforms.
• Solid understanding of system validation, regulatory compliance (21 CFR Part 11, GxP, ICH-GCP), and clinical trial processes.
• Strong analytical thinking, problem-solving skills, and ability to manage complex system workflows.
• Excellent communication, documentation, and cross-functional collaboration skills.
• Experience with integrations, data workflows, or reporting tools (Power BI, Tableau) is a plus.

• Competitive salary range: $100,000 – $130,000 annually.
• Comprehensive healthcare coverage including medical, dental, and vision insurance.
• Remote work flexibility with structured collaboration across global teams.
• Retirement savings plans and financial wellness programs.
• Paid time off, holidays, and additional leave benefits.
• Professional development opportunities, certifications, and continuous learning support.
• Exposure to global clinical trial systems and cutting-edge healthcare technologies.