Company Description
Our client is an exciting scale up Software Solutions Provider working at the cutting edge of clinical trials technology. This newly created permanent role will be a fantastic opportunity to become part of a company with an aspirational culture, a defined career path and a leadership team who are open to new ideas and like to say yes!
The Role
The purpose of the role is to work with the Delivery Team and Software Testing Analysts to coordinate and monitor validation activities for study related projects and ensure that validation remains intact throughout a study’s lifecycle according to internal procedures.
Key Responsibilities:
- Ensure artifacts and deliverables for client projects are delivered and approved in a timely manner
- Develop Validation Plans and Reports
- Approve progress of studies through each phase of the study lifecycle
- Ensure validation state of studies is maintained with an emphasis in quality
- Assist in investigations and resolutions for study related deviations and CAPAs
- Work with the Software Testing Analyst to ensure quality in Internal Testing
- Assist other departments and assist in day-to-day scheduling of validation activities where required
You need to have a Bachelors degree in life sciences or equivalent experience. You ideally have minimum 3 years’ experience in the clinical research field, ideally within RTSM/IRT services delivery of quality assurance. You need to have knowledge of FDA, GCP, ICH guidelines as well as electronic records, 21 CFR Part 11, EU Annex 11 and associated regulatory guidance documents. You will have strong technical writing skills and the ability to demonstrate resilience in prioritising quality against time constraints.