Validation Manager (Contractor) at TrialSpark
Validation Manager (Contractor)
TrialSpark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process. We’re fundamentally changing how clinical trials are run, rethinking the trial process both from a technology and operational perspective. To achieve this, we’re bringing together talent from top technology, CRO, and biopharma companies to work side by side.
This will be a full-time (40 hours/week) contractor position available for ~3 months (starting immediately). At the end of the contract, there will be an evaluation to extend the contract for additional months.
- Develop and manage GxP system lifecycle documentation including Validation Plans, Testing Protocols (IQ,OQ,PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOPs, Change Control Documentation and Risk Management Reports.
- Develop/write test scripts and plans to ensure software functions as expected.
- Lead and manage the compliance status and validation activities of computerized systems in accordance with current regulatory requirements.
- Minimize business risk associated with the processing and storage of electronic documentation ensuring continuity over the system /product lifecycle.
- Support and execute against validation strategic plan which delivers compliant systems that are cost effective with long term sustainable components.
- Develop and manage KPIs for CSV and manage the scheduling of all validation activities within the business.
- Be an industry expert on computer system validation strategy
- Ability to design, write, and execute IQ/OQ/PQ/UAT test scripts
- Deep knowledge of GAMP 5 standards
- Ensure compliance with regulatory requirements and GxP
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.