Data Manager

Newcastle University; Newcastle upon Tyne; On-site; GBP 36,000 - 46,000; Full time

Benefits offered by this job

Excellent benefits

Generous holiday package

Pension schemes

Health and wellbeing initiatives

Job summary

Newcastle University is seeking a Data Manager to ensure the smooth running of data across a portfolio of clinical trials. You will work with investigators, trial teams and statisticians to design, implement and manage data capture and randomisation systems.

The role requires strong organisational and regulatory knowledge, experience with data management systems, and a proactive, detail-oriented approach. The University offers excellent benefits and flexible working arrangements.

Qualifications

• Experience in data management for clinical trials.
• Knowledge of GCP and data protection guidance.
• Experience with regulatory requirements for UK trials.
• Experience designing and managing databases.

Responsibilities

• Design, develop and maintain databases and data capture systems for clinical trials.
• Oversee data collection and input into computerised databases.
• Perform regular data cleaning and quality controls.
• Prepare data for analysis and reporting as required.
• Contribute to trial documentation and training.

Skills

Data management

Database design

Regulatory compliance

Attention to detail

Communication skills

Education

Degree in a relevant subject

Tools

Red Pill

ENNOV

RedCAP

Sealed Envelope

Job description

The Role

Salary: £35,608 - £37,694 with progression to £46,049 per annum

Closing Date: 7 October 2026

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.

Newcastle Clinical Trials Unit (NCTU) is a thriving UKCRC Registered academic unit, working in collaboration with investigators to design and deliver clinical trials that answer important clinical questions and bring meaningful impact to patients and the NHS. We are delighted to share an exciting opportunity for a Data Manager to join our successful and evolving team.

As a Data Manager, you will play a pivotal role in ensuring the smooth running of all data aspects across a portfolio of clinical trials. You will work closely with Chief Investigators, trial teams, database providers, statisticians and other specialists to design, develop and manage high-quality data capture and randomisation systems. Your work will ensure data integrity and compliance with regulatory standards, enabling robust statistical analysis and impactful trial outcomes.

You will be responsible for the set-up and maintenance of computerised databases and non-computerised datasets, data cleaning and validation, and preparation of data for reporting and analysis.

You will also contribute to trial documentation, training, and internal quality improvement initiatives. The role requires a proactive and detail-oriented individual with strong organisational, communication and technical skills.

If you are enthusiastic about clinical research and have experience in data management, database design, and regulatory compliance, we would love to hear from you. For informal enquiries, please contact Dr Naomi McGregor ([e-mail]).

We have 1 full time role available. The role is, permanent 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, with at least 50% office based 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. Red Pill, ENNOV, RedCAP)


• 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 and ENNOV)


• 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 or other data collection tools


• Enable accurate, complete and timely entry of all study data


• Take responsibility for performing regular and timely data cleaning procedures, and quality controls to ensure that all trial data is accurate, complete and timely, using a risk-based process. Identifying and following up any data omissions or queries, identifying potential problems and taking appropriate action


• Prepare data for analysis as required by the statistician including coding as required (e.g. MedDRA)


• 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 the trial management team


• CI's, PI's, statisticians, quality assurance, health economists and other specialists


• Participate in trials risk assessment procedures, leading and advising on the data aspects and feeding these decisions into the development of trial processes and documentation. Lead the preparation of data management plans, data validation plans, and associated documentation


• Provide data and metrics to support monitoring of the trial by the Data Manager or wider trial team.


• Provide data and metrics within CTU, to the Trial Management Group, and both facilitate and assist in the preparation of progress reports for Funders, Ethics Committees, Trial Steering and Independent Data Monitoring Committees, and other bodies, performing some basic descriptive analyses of data, and presenting results in a format suitable for reporting


• Ensure accurate and thorough documentation of all data management activities in accordance with applicable legislation, relevant guidance and current standard operating procedures


• Ensure studies are conducted in accordance with unit processes, GCP and other applicable legislation for Clinical Trials, and the General Data Protection Regulation


• Ensure secure back up of all trial data


• 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


• Contribute to internal NCTU staff training regarding data collection management systems, data management, randomisation systems and related processes


• 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


• Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators


• Any other duties, appropriate to the grade, and which may include line management of staff within the unit

The Person

Knowledge, Skills and Experience

• High levels of literacy and numeracy


• 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


• Excellent organisational and administrative skills


• Ability to use initiative while being aware of circumstances which require the involvement of CI's, trial statisticians, quality assurance and (senior) trial managers


• Knowledge of good data management principles


• 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


• 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

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, ENNOV Red Pill)


• Knowledge of Clinical Trial Methodology


• Experience of data analysis


• 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

• Excellent interpersonal skills


• Excellent attention to detail


• Excellent communication skills


• Ability to adapt and work effectively in different situations and teams. Receptive and contributes to new ideas and approaches and adapts accordingly


• Willingness to travel occasionally outside of the Newcastle area for trial meetings and training

Qualifications

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

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 Gold 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.