Senior Clinical Trials IT Business Analyst
New
USFull-TimeSenior
Salary100,000 - 130,000 USD per year
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Job Details
- Experience
- Minimum of 3 years
- Required Skills
- Business Analysis
Requirements
- Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or 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 with clinical or laboratory systems such as LIMS/LIS (e.g., STARLIMS).
- Understanding of system validation, regulatory compliance (21 CFR Part 11, GxP, ICH-GCP).
- Analytical thinking and ability to manage complex system workflows.
- Strong communication and cross-functional collaboration skills.
- Experience with integrations, data workflows, or reporting tools (Power BI, Tableau) is a plus.
Responsibilities
- Gather, analyze, and document detailed business, functional, and technical requirements.
- Develop BRDs, user stories, functional specifications, process flows, and data flow diagrams.
- Lead implementation and lifecycle management of clinical systems like LIMS, LIS, and ELM.
- Oversee system validation (CSV/CSA), including test planning and IQ/OQ/PQ documentation.
- Lead User Acceptance Testing (UAT), defect tracking, and deployment stabilization.
- Collaborate with IT, vendors, and stakeholders on system integration and data governance.
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