Senior Clinical Trials IT Business Analyst
New
R
Rochester Regional HealthClinical Research IT
United StatesFull-TimeSenior
Salary100,000 - 130,000 USD per year
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Job Details
- Experience
- 3 years of experience in clinical research and/or clinical IT systems; 3 years in Business Analysis within regulated (GxP) environments.
- 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 21 CFR Part 11, ICH-GCP, and FDA regulatory standards.
- Experience with system validation and regulatory compliance.
- Familiarity with system integrations and data workflows.
- Technical fluency in enterprise applications.
- Strong analytical and systems-thinking mindset.
- Experience with Agile, PMBOK, or hybrid project methodologies.
- Excellent communication and documentation skills.
Responsibilities
- Obtain, analyze, and document detailed business, functional, and technical requirements.
- Lead or support the implementation, upgrade, and maintenance of clinical systems including LIMS, LIS, and Electronic Lab Notebooks.
- Support Computer System Validation (CSV) and Computer System Assurance (CSA) activities to ensure GxP compliance.
- Collaborate with IT architecture teams on system integrations such as APIs, HL7, and middleware.
- Lead User Acceptance Testing (UAT), including developing test scripts and managing defect tracking.
- Act as the primary IT liaison for clinical business stakeholders to facilitate workshops and project planning.
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