Senior Clinical Research Database Manager

at  University of Oxford

ABOUT YOU

Applicants should be educated to degree level or equivalent in a biomedical / allied science field or in computer science, or have significant equivalent professional experience.

You will also need to demonstrate that you have:

• An understanding of the role of data management in contributing to the conduct of high-quality clinical trials and compliance with regulatory standards such as GCP and the UK Clinical Trials Regulations.
• Experience of developing and delivering data management plans and working with complex databases.
• Experience of designing electronic Case Report Forms, including knowledge of best practice in CRF design.
• Evidence of significant experience in using programming and data management languages e.g., SQL.
• Ability to work efficiently and prioritise own workload and that of others; experience of working to tight deadlines. Ability to work independently and as part of a team.
• Confidence using Microsoft Office including advanced Microsoft Excel spreadsheets.
• An excellent understanding of Data Protection and Information Security.

Having had previous experience of contributing to costing programming and/or data management activity for funding applications would be a desirable attribute for this post.

We are looking for a Senior Clinical Research Database Manager to join the Oxford Respiratory Trials Unit (ORTU). This is an essential new role in managing all clinical trials databases and staff within the Oxford Respiratory Trials Unit (ORTU). You will need to work closely with Researchers to ensure essential services are provided including forward planning for new trials and research programmes. Input to funding applications will be required.
The post holder will be responsible for leading a small team who design, create and validate clinical research databases. These ensure accurate and highly detailed data capture for a wide range of respiratory trials and related research in the ORTU portfolio. Furthermore, the team manage the databases throughout the life cycle of the trials providing substantial amendments, quality assurance support and data extraction for interim and final data-locks for data analysis and scientific publications.
You will provide oversite, workload management and line management but will also use initiative to drive quality and process improvement ensuring compliance with clinical trial legislative requirements. It is expected that the Senior Manager will lead by example and therefore be hands-on carrying out programming and validation functions whilst also providing leadership and progressing development.