Senior Clinical Trials IT Business Analyst
New
United StatesFull-TimeSenior
Salary100,000 - 130,000 USD per year
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Job Details
- Experience
- 3 years
- Required Skills
- Business Analysis
Requirements
- Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or related field.
- 3 years of experience in clinical research and/or clinical IT systems (e.g., STARLIMS).
- 3 years of experience in Business Analysis within regulated (GxP) environments.
- Understanding of the lab clinical trial lifecycle.
- Experience with system validation and regulatory compliance (21 CFR Part 11, ICH-GCP).
- Knowledge of system integrations, data workflows, APIs, and HL7.
- Analytical and systems-thinking mindset with technical fluency in enterprise applications.
- Cross-functional leadership and vendor management skills.
- Excellent documentation and communication skills.
Responsibilities
- Obtain, analyze, and document detailed business, functional, and technical requirements and develop BRDs and user stories.
- Lead or support implementation, upgrade, and maintenance of clinical systems such as LIMS, LIS, and electronic lab notebooks.
- Support Computer System Validation (CSV) and Computer System Assurance (CSA) activities and ensure compliance with 21 CFR Part 11, ICH-GCP, and other regulatory standards.
- Collaborate with IT architecture teams on system integrations including APIs and middleware.
- Lead User Acceptance Testing (UAT), defect tracking, and system deployment support.
- Act as primary IT liaison for Clinical business stakeholders and support project management methodologies.
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