My client requires a Senior IT CSV Expert able to coach other team members and help on final review of documents. You must have experience of IT regulations related to clinical trials and annex 11.
The initial assignment will be 1 Year with the likely hood of an extension. The role will be a freelance hourly rate paid contract and this is a hybrid role where you will be required on the client site 2 days per week in Braine / Brussels.
· Liaison for local team, Training and integration
· Monitor Key Performance Indicators
· Lead monthly meetings
· Manage Resources, Oversee local team
· Create comprehensive reports, Develop scripts
· Writing documents (protocols) and support stakeholders
(review docs, SOP's,) Coordinate test execution
· Monitor specs, test execution, and defects.
· Act as deputy for for the clients IT Compliance and Lead projects
· 5-10 years Years in CSV - Computer System Validation
· Strong IT Background (Lead Validation Activities)
· PM skills (but this is NOT A PROJECT MANAGER role)
If you are available and have the skills and experience, please respond ASAP as the client would like to hire in December with a January start.