Trial Data Manager

We are looking for a Trial data Manager to be part of this global team with the focus is more on specification than the actual build phase working on a number of Clinical trials across multiple therapeutic areas.

Role

• Implementation, monitoring and supervision of data management activities within assigned clinical trials
• Design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs and their set-up in EDC system, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and Data Management Plans (DMPs).
• Provision of adequate sponsor oversight of data management CROs or external data providers
• Filing and archiving of trial documentation
• Creation and execution of data quality checks throughout study conduct

Experience

• At least 6-10 years’ experience within Clinical Data Management either within a Pharma or CRO environment with a proven track record of quality
• Knowledge in and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods and requirements is a plus
• Understanding of dependencies among interfaces
• Experience in working in/with agile teams and/or as a product owner is a plus
• Ability to independent decision making and problem solving
• Excellent communication and fluency in English in speaking and writing
• Understanding of CDISC standards (CDASH, SDTM, etc.…) and SAS is a plus but essential

This is a long-term engagement working remotely in either the UK/Ireland  or Europe.  If based in the UK this will be outside of IR35.