Salary: £26,642 to £27,344 with progression to £28,879 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 February 2025
The Role
This is an exciting opportunity to join the university as a Data Manager assisting with the management of observational nationwide clinical studies, supporting the Newcastle National Institute for Health and Care (NIHR) Biomedical Research Centre (BRC) Liver Theme.
In this role, you’ll be based at our Newcastle Upon Tyne campus that has fantastic transport links and state of the art facilities. You’ll report to Prof Helen Reeves.
We offer a hybrid and flexible working model, meaning you can plan your working hours and days in the office around any personal responsibilities you may have.
Day to day, 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.
Analysing large patient cohorts, liver theme investigators are conducting research focused on (1) the progression of liver disease to cirrhosis and primary liver cancer, called hepatocellular carcinoma, (2) the identification of biomarkers predicting response to therapy and (3) novel therapeutic target discovery.
This is a full time post, fixed term for a 2 year period.
To apply for the position, we’ll need a copy of your CV which should outline how you are suitable for the role, with a particular focus on the essential criteria in the knowledge, skills and experience as listed in the job description.
If you would like to ask any questions or request any further information prior to applying, please contact Helen.Reeves@ncl.ac.uk
Key Accountabilities
1. Transcription of data from patient records to Case Report Forms as required by a specific clinical trial.
2. Liaising with a range of internal and external interested parties such as senior clinical and non-clinical staff, funders, PI’s and nursing staff.
3. Ensure that all data reporting requirements both internally and externally are met.
4. Take responsibility for all data security and integrity in line with University and Trust policies.
5. Ensure adherence to Data Protection/Caldicott Guidelines.
6. Collation of information for reporting of Serious Adverse Events (SAE’s).
7. Register and randomise patients into clinical trials.
8. Ensure patient investigation results are received and recorded appropriately.
9. Order supplies of data capture documentation.
10. Act as a point of contact for regional, national and international data queries.
11. Organise meetings for monitors and/or auditors.
12. Audit data quality on manual and electronic systems.
13. Assist the Clinical Trials Co-ordinators in maintaining records of patients on trials.
14. Help with the preparation for audits and inspections.
15. Ensure archival of closed study documentation is completed.
16. Provide administrative support when needed.
17. Take responsibility for continuous improvement of research administrative processes.
18. Identify own learning needs and undertake personal development training.
19. Work in accordance with applicable regulations and guidance.
20. Assist with other research administrative functions.
21. Make decisions when transcribing data into Case Report Forms.
The Person
Knowledge, Skills and Experience
1. Knowledge of medical terminology.
2. Knowledge of University and Trust policies regarding Data Protection Act and the Caldicott Guidelines.
3. Experienced in all aspects of Microsoft Windows applications.
4. Excellent interpersonal and communication skills.
5. Good time management skills.
6. Ability to prioritise workloads.
7. Ability to accurately transfer data.
8. Previous Database and Data Management experience.
9. Evidence of Admin and Clerical experience.
10. Experience within NHS/clinical research.
Desirable
1. Knowledge of liver disease and liver cancer terminology.
2. An understanding of Good Clinical Practice (GCP).
3. Demonstration of a knowledge of Serious Adverse Event (SAE) procedures.
4. Knowledge of E-Record.
Attributes and Behaviour
1. Meticulous about following processes and procedures.
2. Self motivated and able to work with minimum supervision.
3. Willing to undertake personal development training.
4. Flexibility to work unsocial hours when necessary.
5. Able to work flexibly across both NUTCRI and Newcastle-upon-Tyne Hospitals NHS Foundation Trust.
Qualifications
1. Educated to A level standard or equivalent.
Desirable
1. European Computer Driving licence qualification or equivalent.
Newcastle University is a global University where everyone is treated with dignity and respect. We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society. We value diversity and celebrate the contributions of all of our employees.
At Newcastle University we hold a silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality.
We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education.
We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role.
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