Data Manager

Newcastle, GB

Newcastle University

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Salary: £35,116.00 - £45,413.00  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: 24 April 2025

 

The Role


This is an exciting opportunity to join a dynamic, international, multidisciplinary team working in the area of translational research for neuromuscular diseases within the John Walton Muscular Dystrophy Research Centre at Newcastle University.

 

This exciting role will take responsibility for ensuring the smooth running of all data aspects related to the Adult SMA Reach network including overseeing the computerised database for the capture (including electronic remote data capture and randomisation systems) and the management of data within the study.

 

You will be responsible for the design, set-up and management of computerised database for the capture (including electronic remote data capture and randomisation systems) and the management of data within this study. You will be responsible for identifying and establishing processes to ensure the highest level of data integrity, ensuring data is suitable for statistical analyses and for undertaking statistical analyses with the data from the Adult SMA Reach Study. These systems and data will meet the quality standards expected for reporting to regulatory bodies and in accordance with all applicable legislation and Good Clinical Practice guidelines.  

 

Further to this, you will lead a review of John Walton Muscular Dystrophy approaches to data management and data security to develop good practice model supported by clear Standard Operating Procedures (SOPs) for data management in a team that must comply with both Newcastle University and Newcastle upon Tyne Hospital Trust data management policies. 

 

You will hold a degree qualification in a relevant subject or equivalent relevant experience in a senior role. You will have experience of data management and standard statistical analysis and may be looking for an opportunity to specialize in specific disease area. You will have knowledge and hand-on experience of statistical software and clinical data management systems. You will be proactive, attention to detail and possess excellent organisational skills, with proven ability to manage resources effectively and deliver results on time. Flexibility and willingness to travel and work across two sites (Newcastle and North Tess Hospital NHS Foundation Trusts) will also be required for this role. 

 

This position is available on a full time (37 hours per week), fixed term basis, to start immediately until December 2026. 

 

For all informal enquiries, please contact Chiara Marini Bettolo, chiara.marini-bettolo@newcastle.ac.uk

 

For more information about the Faculty of Medical Sciences, please click here.  


For more information about our Research Institutes, please click here.  

 

For more information about the John Walton Muscular Dystrophy Research Centre please click here.

 

To apply, please complete an online application and upload a plain text copy of your CV and covering letter only. In your covering letter, you should evidence how you meet or exceed the essential and desirable requirements for the role. Please note, any other ‘Additional Document’ you upload may not be received by the reviewing panel.

 

Key Accountabilities

  • Design, develop, test and maintain database and data capture systems for the Adult SMA network documenting each element in line with relevant SOP’s using one or more proprietary Clinical Data Management System packages)
  • Design, develop, test and train staff to maintain other databases (e.g. Access) to support the administration of clinical trials
  • Enable accurate, complete and timely entry of all study data
  • Work closely with the Study PI and steering group in contributing to the design of data collection forms for the Adult SMA Reach study.
  • Oversee the collection and collation of data collection forms from participating centres and ensure the input of this data onto computerised databases as needed
  • Work closely with the study manager to perform regular and timely data cleaning procedures, and quality controls to ensure that all trial data is accurate, complete and timely, identifying and following up any data omissions or queries, identifying potential problems and taking appropriate action
  • Ensure good working relationships between the John Walton Muscular Dystrophy Research Centre and its clinical, academic and other partners and collaborators, particularly the partners in the Adult SMA network to ensure all collaborating centres provide timely responses to data queries
  • Prepare data for analysis and perform statistical analysis
  • Prepare data management plans and ensure accurate and thorough documentation of all data management activities in accordance with applicable legislation and current standard operating procedures
  • Provide data to the Trial Management Group to facilitate the preparation of progress reports for Funders, Ethics Committees, Trial Steering Committees, Independent Data Monitoring and Ethics Committees, and other bodies, performing basic descriptive analyses of data, and presenting results in a format suitable for reporting
  • Assist in the preparation of data and materials for publication and/or presentation at scientific meetings or in scientific journals
  • Give presentations and provide training on the effective use of data capture systems including development of trial specific user manuals nationally through the SMA Adult Network
  • Ensure studies are conducted in accordance with GCP and other applicable legislation for Clinical Trials, and the General Data Protection Regulation
  • Ensure secure back up of all study data
  • Contribute to, and lead on, writing and reviewing of JWMDRC SOP’s and policy documents on data collection and management systems and processes, including the review of quality improvement and other related initiatives
  • Be able to plan and organise own workload and supervise that of others when required
  • Use initiative while being aware of circumstances which require the involvement of CI’s, PI’s trial statisticians and trial managers
  • Work with Investigators and the wider research team in planning data collection systems and data management
  • Attend internal and external meetings as the expert in database and data management and develop close and effective working relationships with CI’s, PI’s, statisticians, health economists, other specialists and the trial management team
  • Complete a data management risk assessment for the John Walton Muscular Dystrophy Research Centre
  • Coordinate an assessment of training needs in the John Walton Muscular Dystrophy Research Centre regards data management, data transfer and develop centre policies, SOPs and induction materials to minimise risks identified in the above
  • Contribute to internal JWMDRC staff training regarding data collection management systems, data management, randomisation systems and related processes. Offer support and advice for basic statistical analyses
  • Any other duties, appropriate to the grade, which may be required from time to time by the JWMDRC

 

The Person (Essential)

 

Knowledge, Skills and Experience 

  • High levels of literacy and numeracy
  • Knowledge of good data management principles
  • Evidence of ability to set up, maintain and manage an effective research data management system, which produces reports and raises queries e.g. web-based CRF
  • Excellent IT skills including the use of the Microsoft Office Package
  • Ability to prioritise and manage workload using your initiative as required
  • Ability to make independent decisions and to work independently, alongside excellent team working skills
  • Working knowledge of regulatory and governance requirements for clinical trials in the UK
  • An understanding of the requirement of data protection regulations, the need for confidentiality and the ability to work to these
  • Appropriately handle confidential and sensitive information
  • Experience of database design
  • Experience of data management, data checking, data cleaning and reporting
  • Excellent organisational and administrative skills

(Desirable)

  • Knowledge and hands-on experience of statistical software
  • Knowledge and hands-on experience of SQL programming
  • Knowledge and hands-on experience of Clinical Data Management Systems (e.g. MACRO)
  • Knowledge of Clinical Trial Methodology
  • Experience of working on an interventional clinical trial
  • Experience of working in a University or NHS environment
  • An understanding of data collection in an NHS environment

 

Attributes and Behaviour (Essential)

  • Excellent interpersonal skills
  • Excellent attention to detail
  • Excellent communication skills
  • Flexible approach to working
  • Willingness to travel to trial sites and to trial meetings as required
  • Willingness to work at each of the two NCTU sites located in Newcastle and South Tees Hospitals NHS Foundation Trust

 

Qualifications (Essential)

  • Degree in a relevant subject (or equivalent relevant experience in a senior role)

(Desirable)

  • Higher degree in a relevant subject

 

Newcastle University is a global University where everyone is treated with dignity and respect.  As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.

 

We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society.  We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.

 

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 REC.  We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.

 

In addition, we are a member of the Euraxess initiative supporting researchers in Europe. 

Requisition ID: 28055

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Category: Leadership Jobs

Tags: Athena Data management GCP Research Security SQL Statistics

Perks/benefits: Flex hours Health care Startup environment

Region: Europe
Country: United Kingdom

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