Are you looking for a change?
Our client is a rapidly expanding medical devise manufacturer who is looking for a new Data manager to join the team.
Provide data management services to support the clinical study teams based in both Glasgow and Sunrise (Fort Lauderdale)
- Clinical data management support
- Reviews of clinical research documents
- Develop data management plans
- Develop case report forms
- Lead the process of determining EDC database specification
- Responsible for implementing EDC build or managing 3rd party vendors build of EDC system
- Develops Data Transfer Agreement(s)
- Develop test scripts and execution logs for User Acceptance Testing (UAT) of EDC systems.
- Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trial.
- Perform training on study trial for EDC and create user guides.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Coordinate the archiving of study databases and related documents.
- Perform close-out audit, as specified, for closing of study trial in EDC
- Assist in reconciling AE/SAE data including performing MedDRA coding.
- Prepare data for presentations (internal and external)
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
- Bachelors degree in a science or mathematical related fields
- Minimum 2 years data management experience within the scientific industry
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC and CTMS.
- Experience of AE Coding
Up to £40,000 depending on experience
Basic benefits package
Monday to Friday (1.30pm finish on a Friday.)
Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.