RAVE SME - Data Management - Home Based
CK Group are recruiting for a Clinical Data Management, Manager, to join a small but growing Data Management team - not just to deliver data management for this exciting portfolio of studies, but to help shape and influence how a Pharmaceutical Company drives data management excellence for the future. This role can be site or home based with occasional visits to the site in Cambridge on a permanent basis.
Principal responsibilities will include:
- Be responsible and accountable for planning, organisation, leadership and coordination of all data management activities on assigned projects (Phase I to IV) right from the database set-up to project closure with minimum supervision.
- Work closely with Data Management vendors to ensure quality and timely data management deliverables.
- Utilise your Medidata Rave knowledge (including RAVE screen build and edit check programming)
- To be the RAVE EDC subject matter expert supporting DM colleagues and assigned CROs.
- You will spend approximately 50% of time as the Data Management Study Lead and 50% in the RAVE SME role.
- Bachelor's or Master's Degree in Life Sciences
- Demonstrate sound knowledge of Drug Development Process and Clinical Data Management processes
- Extensive experience in Clinical Data Management in the pharmaceutical industry
- Strong experience of Medidata Rave eCRF screen build and edit check programming (SME level)
- Good Knowledge of ICH and GCP guidelines
- Experience leading projects from study start-up to database lock.
Full job description available upon request.
For more information or to apply for this position, please contact Stephanie Maccioni on 01438 768713 or email email@example.com, quoting job ref 48404.
It is essential that applicants hold entitlement to work in the UK.