Job Summary
A research organization is filling a position for a Remote Computer Systems Validation Manager.
Core Responsibilities Include:
- Conducting or facilitating validation and 21 CFR Part 11 training
- Writing Test Scripts and create Traceability Matrix and Test Reports
- Analyzing data, prepare and review test results, and write validation reports
Applicants must meet the following qualifications:
- 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 querie
- 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
