Requisition ID: 26027
Location:
Newcastle, GB
Contract Type: Open Ended
Working Pattern: Full Time
Posted Date: 14 Aug 2023
Salary: £33,966 to £36,024 with progression to £44,263 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: 10 September 2023
The Role
Newcastle Clinical Trials Unit (NCTU) is a thriving registered academic unit, working in collaboration with investigators to design and deliver clinical trials answering important clinical questions, whose findings bring substantial impact to patients and the NHS. We are delighted to share with you an exciting opportunity for a Data Manager within our successful and expanding UKCRC Registered Clinical Trials Unit.
You will work within a multi-disciplinary team including Trial and Data Managers and Trial Statisticians to ensure that clinical trials are delivered in line with sponsor, regulatory and research governance requirements.
We currently have approximately 40 active trials and studies, and work with multiple trial sponsors locally, nationally and internationally from two hubs in Newcastle (main hub) and South Tees. You may be expected to work at both sites depending on the needs of individual trials and NCTU.
We are looking for people who are enthusiastic and motivated, with excellent communication and interpersonal skills. If this is you, please contact Dr Alaa Abouhajar at alaa.abouhajar@newcastle.ac.uk or Jon Prichard at jonathan.prichard@newcastle.ac.uk.
To read more about how we make a difference please click here.
The role is full time, but we are keen to hear from people who may wish to discuss flexible working arrangements. We can offer a blended approach to home and office working.
Key Accountabilities
- Design, develop, test and maintain databases and data capture systems for clinical trials documenting each element in line with relevant SOP’s using one or more proprietary Clinical Data Management System packages (e.g. MACRO, Red Pill)
- Design, develop, test and maintain randomisation systems for clinical trials documenting each element in line with relevant SOP’s using one or more systems (e.g. Sealed Envelope)
- Design, develop, test and maintain other databases (e.g. MS Access) to support the administration of clinical trials
- Enable accurate, complete and timely entry of all study data
- Work closely with the trial management group in contributing to the design of data collection forms
- Oversee the collection and collation of data collection forms from participating centres and ensure the input of this data onto computerised databases as needed
- Take responsibility for performing 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 NCTU and its clinical, academic and other partners and collaborators
- Prepare data for analysis as required by the statistician including coding as required (e.g. MedDRA)
- Lead the preparation of data management plans, data validation 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, and both facilitate and assist in the preparation of progress reports for Funders, Ethics Committees, Trial Steering Committees, Independent Data Monitoring and Ethics Committees, and other bodies, performing some 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
- 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 trial data
- Contribute to writing and reviewing of 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, trial statisticians and trial managers
- Work with Chief 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
- Contribute to internal NCTU staff training regarding data collection management systems, data management, randomisation systems and related processes
- Any other duties, appropriate to the grade, and which may include line management of staff within the unit
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
- Knowledge and hands-on experience of statistical software (Desirable)
- Knowledge and hands-on experience of SQL programming (Desirable)
- Knowledge and hands-on experience of Clinical Data Management Systems (e.g., MACRO, Red Pill) (Desirable)
- Knowledge of Clinical Trial Methodology (Desirable)
- Experience of data analysis (Desirable)
- Experience of working on an interventional clinical trial (Desirable)
- Experience of working in a University or NHS environment (Desirable)
- An understanding of data collection in an NHS environment (Desirable)
Attributes and Behaviour
- Excellent interpersonal skills
- Excellent attention to detail
- Excellent communication skills
- Flexible approach to working
- Willingness to travel occasionally outside of the Newcastle and South Tees areas for trial meetings and training
Qualifications
- Degree in a relevant subject (or equivalent relevant experience)
- Higher degree in a relevant subject (Desirable)
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.
In addition, we are a member of the Euraxess initiative supporting researchers in Europe.
Requisition ID: 26027