Salary: £26,942 - £27,644, with progression to £29,179 per annum
Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.
Closing Date: 17 April 2025

KEY ACCOUNTABILITIES

• To be responsible for the overall day-to-day administration of the European SLD Registry, NASH-DTA ADVANCE and sample databases to ensure complete data sets are available for analysis and act early to address any missing data points, in line with the Monitoring Plan, including data entry into the system.
• To work with recruiting sites to ensure samples are transferred to local or central biobanks in a timely manner and validate sample inventories.
• To be responsible for the cleansing and importing external datasets into the European SLD Registry.
• To support the lead Data Manager in all aspects of maintaining records of patients on trials and the regulatory issues that govern the management of clinical trials and associated projects.
• To produce regular reports on registry and sample metrics.
• To act as the main point of contact for the partner sites and the Data Manager for data entry queries and support.
• To provide advice and training to sites on the use of the European SLD Registry and NASH-DTA ADVANCE Databases
• To work with analyst teams, and external researchers, to review data and to proactively check required data. This will include working with external researchers from industry and academia requesting clinical data on approval of data requests by the relevant academic project lead.
• To ensure data quality of the European SLD Registry, NASH-DTA ADVANCE and Sample Databases to ensure that high standards are met and comply with University, Trust and external governing bodies’ requirements.
• To be assist with the preparation and facilitation of audits and/or inspections.
• To take responsibility for all data security and integrity in line with University and Trust policies.
• To be responsible for ensuring that University and Trust policies in relation to Data Protection/Caldicott Guidelines are adhered to, including checking that all data capture systems used comply with this.
• Be aware of and take responsibility for working in accordance with applicable regulations and guidance including the International Conference on Harmonisation (ICH) Guidelines on Good Clinical Practice, UK Regulations on Clinical Trials, Data Protection Act, and Research Governance Framework for Health and Social Care
• To work with researchers and partners to ensure that data is prepared for analysis in advance of analysis team meetings
• To provide administrative support when needed as directed by the line manager. This may include supporting the administration of submissions to journals or conferences.
• To support links between the European SLD Registry and other projects as required.
• To initiate requests for data/material transfer agreements and to keep a record of the status of these agreements
• To provide data administration support for other projects as required, including supporting the development of new databases.
• Take responsibility for continuous improvement of research administrative processes and target achievement, in line with changing regulations and faculty strategy.
• Take responsibility for identifying own learning needs, including identifying appropriate courses to ensure up to date knowledge in the regulations governing clinical research and research data.

You will join the data management team of the international “European SLD Registry” and the “NASH-DTA” studies to support research being undertaken by members of the Newcastle NIHR BRC Liver Theme.
Analysing large patient cohorts and linked biological samples, liver theme investigators are conducting research focused on (1) the progression of metabolic dysfunction associated steatotic liver disease (MASLD) to cirrhsis and liver cancer, (2) the identification of new biomarkers for risk-stratification and predicting disease outcomes and (3) novel therapeutic target discovery. The European SLD Registry is a large database bringing together clinical data and biological samples from across Europe that underpins much of this research. These studies will be important in the development of better diagnostics to monitor MASLD progression and to help identify new ways to treat cirrhosis.
The main purpose of this role is to work with staff at the ~40 study sites, central and local biobanks and the lead Data Manager in Newcastle to ensure that the data set is as complete and robust as possible and samples are transported and processed in a timely manner.
You will assist with the management of projects professionally and in accordance with relevant regulations from first customer contact through to archival of project documentation; providing evidence demonstrating that the research conducted in NUTCRI and Newcastle-upon-Tyne NHS Hospitals Foundation Trust safeguards the wellbeing of patients and produces credible data.
This post is tenable for up to 2 years.
For informal enquiries contact Kristy Wonders (Kristy.wonders@newcastle.ac.uk).
To apply, please provide evidence of how you meet the essential criteria required for the role outlined in ‘The Person’ by uploading a letter of application along with your Curriculum Vitae (CV).
Find out more about the Faculty of Medical Sciences here: https://www.ncl.ac.uk/medical-sciences/
Find out more about our Research Institutes here: https://www.ncl.ac.uk/medical-sciences/research/institutes/
As part of our commitment to career development for research colleagues, the University has developed 3 levels of research role profiles. These profiles set out firstly the generic competences and responsibilities expected of role holders at each level and secondly the general qualifications and experiences needed for entry at a particular level.
Please note that if you are successful to this role, you will require medical clearance before you can commence in the role