Computer System Validation Analyst R Studio Clinical Systems
Computer System Validation Analyst R Studio Clinical Systems
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Salary Not Disclosed
1 Vacancy
Job Description
- Lead validation planning risk assessment and for R Studio GitLab and Medidata Rave EDC.
- Develop and execute validation documentation including:
- Validation Plans (VP..
- User Requirements Specifications (URS..
- Risk Assessments (RA..
- Functional and Design Specifications.
- Traceability Matrix (RTM..
- Test Protocols (IQ/OQ/PQ or CSAbased scripts..
- Validation Summary Reports (VSR..
- Collaborate with crossfunctional stakeholders including Clinical Data Management Biostatistics IT and QA teams to gather requirements and ensure system compliance.
- Coordinate and document test evidence in systems such as Val Genesis Kneat or other evalidation platforms.
- Perform gap assessments periodic reviews and change control assessments for validated systems.
- Ensure compliance with 21 CFR Part 11 Annex 11 ICH E6(R2 GAMP 5 and FDA CSA Guidance.
- Support audit readiness by maintaining validation documentation and providing responses to internal/external auditors.
- We are seeking a Computer System Validation (CSV) Engineer with strong experience validating statistical programming environments (R Studio) source code management systems (GitLab) and Clinical Data Management Systems such as Metadata Rave EDC.
- The ideal candidate will be responsible for ensuring GxP compliance data integrity and adherence to Computer Software Assurance (CSA) principles throughout the validation lifecycle.
- Bachelors degree in computer science Life Sciences or related field.
- 5 years of experience in Computer System Validation in a regulated GxP environment.
- Handson validation experience with GitLab and Medidata Rave EDC.
- Strong understanding of FDA regulations 21 CFR Part 11 data integrity and CSA methodology.
- Experience with electronic validation lifecycle systems (Val Genesis Kneat etc..
- Strong documentation analytical and communication skills.
- Knowledge of SDLC methodologies including Agile/DevOps validation frameworks.
- Familiarity with clinical trials data and statistical programming environments.
- CSA training or certification is a plus.
Employment Type
Remote
Company Industry
Key Skills
- SQL
- System Design
- .NET
- Crystal Reports
- EDI
- Windows
- Microsoft SQL Server
- Visio
- Visual Basic
- SDLC
- Systems Analysis
- Oracle
