Job Summary
A company is looking for a Senior Clinical Systems Analyst.
Key Responsibilities
- Gather user requirements and translate them into detailed technical specifications for solution design and implementation
- Develop documentation for project implementation, including user access/training plans, communication materials, and end user guides
- Lead and execute test scripts, facilitate UAT, and ensure successful adoption across clinical development functions
Required Qualifications
- Bachelor's degree required
- 5+ years of clinical technology/clinical systems manager-level experience within the pharma/biotech industry - required
- GxP systems implementation and support experience - required
- Knowledge of 21 CFR Part 11, GAMP 5, and related FDA regulations - required
- Veeva Clinical Vault or eClinical solutions like elluminate is preferred
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