Job Summary
A medical clinical trials company is in need of a Telecommute Computer Systems Validation Manager.
Individual must be able to fulfill the following responsibilities:
- Conduct or facilitate validation and 21 CFR Part 11 training
- Lead, mentor and guide staff on industry compliance related matters
- Perform risk analysis to determine validation deliverables needed for a project
Must meet the following requirements for consideration:
- Requires a bachelor’s degree
- 10+ years’ experience in computer systems validation, including significant experience working with minimal direction
- Clinical data analysis, hands on experience working with relational DBMS technologies (Oracle, MS SQL), able to write and run basic SQL queries
- Experience validating cloud/externally hosted clinical systems
- Detailed knowledge of computer system validation and all GCP (Good Clinical Practice) regulations
- Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
