Position Details
About this role
This role involves supporting the validation of clinical trial software, ensuring compliance with industry standards, and maintaining validation documentation.
Key Responsibilities
- Participate in validation activities
- Develop validation deliverables
- Ensure compliance with regulations
- Support customer validation
- Maintain validation documentation
Technical Overview
The technical environment includes clinical trial software validation, GCP guidance, 21 CFR Part 11, EU Annex 11, and technical writing for validation deliverables.
Ideal Candidate
The ideal candidate is a CSV professional with at least 1 year of experience in clinical trial software validation, strong technical writing skills, and knowledge of GCP and regulatory standards. They should be detail-oriented and capable of supporting validation activities in a fast-paced environment.
Must-Have Skills
Nice-to-Have Skills
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 1 year of CSV experience, Lack of knowledge of GCP, 21 CFR Part 11, EU Annex 11, No technical writing skills
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