Senior Data Manager
Stephanie Maccioni is recruiting for a Senior Data 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 is site or home based with regular visits to their site in Cambridge on a permanent basis.
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 till project closure with minimum supervision; works closely with Data Management vendors to ensures quality and timely data management deliverables.Principal responsibilities will include to:
- Be responsible for performing all tasks in adherence to GCP guidelines and maintain Health & Safety knowledge applicable to the job.
- Oversee all project related data management activities for outsourced projects including but not limited to, CRF design, data collection, edit checks & offline listings review, external data reconciliation, Serious Adverse Event reconciliation, medical coding, quality control of database, database locks and archival of data management documents.
- Liaise with the team and Data Management vendor to ensure Serious Adverse Events reconciliation is completed at agreed intervals.
- Liaise with external vendors and Data Management vendor team to facilitate Data Transfer Specifications are created/reviewed/approved and the transfer files are sent at agreed intervals.
- Ensure the in-house data review is scheduled and completed in a timely manner and co-ordinate the data review by clinical, medical and stats teams.
- 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 working on both paper and EDC (preferably Medidata RAVE) studies.
- Good Knowledge of ICH and GCP guidelines.
Full job description available upon request.
For more information or to apply for this position, please contact Stephanie Maccioni on 01438 768713 or email firstname.lastname@example.org. Alternatively please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46492 in all correspondence.