Remote Job
Analyst - Computer Software Validation (Remote)
Veeva Systems- 5000 - 6000 USD per Month
- Full Time
- Posted : 12 months ago
We are looking for a Computer Software Validation (CSV) professional with a specialty in clinical trial software. This role would give you the opportunity to work on a leading solution in Randomization and Trial Supply Management (RTSM) software. To excel in this role you will require strong technical writing capabilities and the ability to simplify complex topics.
- Participate in RTSM requirement gathering sessions with clients and RTSM team members
- Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
- Ensure requirements are adequately tested following a risk-based approach
- Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices
- Manage Validation testing cycles and resolution of issues and enhancement requests
- Maintain change control documentation to ensure ongoing validation of the RTSM system
- Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements
- Support customers as needed in RTSM validation activities
- 1+ year of experience in a CSV for clinical trial software (CTMS, CDMS, eTMF, etc.)
- Working knowledge of software development cycle (SDLC)
- Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
- Exceptional attention to detail
- Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels
- Familiarity with the conduct of clinical trials
- Previous experience with RTSM
- Expert in Microsoft Word and Excel
- Work from Home
- Flexible PTO
- Medical, Dental, Vision, and 401(k) plans
- Allocations for continuous learning & development
- Fitness and Wellness Reimbursements
- Allocations for donations to the non-profits and charities of your choosing
Skills
- rdms
- gcp
- CTMS
- CSV
- CDMS
- SDLC
- Word
- MS Excel
