Lead Data Manager
An exciting opportunity has arisen for a Lead Data Manager to join a biotechnology organisation in Chesire. As a key member of this clinical team, you will establish, always perform and oversee the setup of the clinical study.
- Have a keen interest in digital technology and driving forward new and innovative technologies within the clinical setting.
- Define and manage clinical data management timelines on multiple studies or programmes
- Coordinate/perform all CDM activities for assigned studies/programmes, including eCRF design, EDC system set up, user acceptance testing, users training, data review, query generation and data coding
- Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
- Ensure appropriate study specific training is provided to assigned clinical study teams
- Generate data analysis status reports on clinical studies for the clinical study teams
Skills and Requirements
- A scientific background, ideally university level and GCP trained
- A minimum of 5 years' experience in clinical data management at a CRO or Pharma with strong experience using major EDC systems and related tools and technologies
- Experience in leading data management studies and teams to timely delivery of quality databases that meet regulatory requirements
- Knowledge and experience of using CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml
- Good planning, organisational and communication skills
- Excellent written and verbal English
- Excellent attention to detail
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at 0203 854 3893 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.