Senior Information Systems & Data Manager

Salary: £47,389 to £50,253 with progression to £56,535 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: 23 March 2026

The Role

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 offer an exceptional opportunity for a Senior Information Systems and Data Manager to join our senior team and lead the strategic development of data management and information systems across the Unit.

In this pivotal leadership role, you will ensure the accuracy, security and integrity of data across a diverse portfolio of clinical trials. You will work closely with Chief Investigators, trial teams, biostatisticians, University IT, and national partners to design, implement and oversee high‑quality data management systems and processes. Your expertise will help ensure that NCTU remains at the forefront of best practice, regulatory compliance and digital innovation in clinical trial data management.

You will lead and develop the Data Management Team, providing strategic direction, professional support and oversight of day‑to‑day operations. You will act as the Unit’s Information Governance Lead, taking responsibility for secure systems to host NHS Digital and other sensitive data, and ensuring robust governance frameworks are in place. You will also play a key role in shaping the Unit’s strategic direction, contributing to quality improvement initiatives, digital solutions and intelligent information systems.

This is a highly collaborative role, requiring excellent communication, leadership and organisational skills, alongside deep knowledge of clinical trial design, regulatory requirements, information governance and data management methodologies. You will represent NCTU nationally, engaging with networks and stakeholders to promote best practice and maintain our position as a leader in clinical trial data management.

If you are an experienced data management professional with a passion for clinical research, digital innovation and high‑quality data systems, we would be delighted to hear from you. For informal enquiries, please contact Helen Hancock (helen.hancock@newcastle.ac.uk).

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The role is a permanent, full time, but we welcome conversations about flexible working arrangements or reduced hours. We offer a blended approach to home and office working, with at least 50% office‑based working.

You will be the Senior Information Systems and Data Management and lead activities across the UKCRC registered Newcastle Clinical Trials Unit (NCTU) to ensure comprehensive data management support to the portfolio of clinical trials run in collaboration with NCTU. You will also establish and maintain links nationally and ensure that NCTU data management processes continue to be compliant with regulatory requirements and at the forefront of recognised best practice.

You will understand and contribute to the scientific, design, regulatory and technical elements of clinical trials; they will lead data management advice to ensure trials are designed, delivered, and the data is managed efficiently, in line with sponsor, regulatory and research governance requirements, and to enable the highest levels of data integrity. They will be expected to appropriately handle confidential and sensitive information. They will manage the Data Management team and other NCTU staff as appropriate and be responsible for clinical data management, randomisation and other appropriate trial systems within NCTU. The Senior Information Systems and Data Manager will be the Information Governance Lead for the Unit, taking responsibility for systems to hold NHS Digital data, and other sensitive data, securely.

There are currently approximately 25 active trials being conducted by NCTU. NCTU works with multiple trial sponsors, locally, nationally and internationally. NCTU’s portfolio includes clinical trials across all phases, in support of NCTU strategic aims. Chief Investigators, Principal Investigators and Co-Investigators as well as methodologists, including biostatisticians are located throughout and beyond the University. The post holder will be expected to travel nationally depending on the needs of individual trials and NCTU.

Primary purpose

• This role is crucial for ensuring the accuracy, security, and consistent quality of data in clinical trials realised through efficient, robust and compliant systems and processes. 
• The role ensures a valued, informed workforce, providing consistent high quality, efficient and compliant clinical data management working effectively as part of wider trial and CTU teams and within the University.

Key Outcomes

• Effective development and management of NCTU’s data management team to deliver consistent quality and compliant clinical trial data. Effective management of resource to achieve this outcome.
• Effective leadership and direction that contributes to the strategic development of the Unit with regard to data and information security
• Lead and direct for the development and continued improvement of data management and data management systems, data governance, digital solutions and the development of intelligent information systems.
• Ensure the highest standards of data security, confidentially and accuracy for NCTU clinical trial portfolio by working with senior IG, NUIT and other colleagues.
• Engage with national networks and stakeholders to ensure CTU remains a leader in best data practises by informing and promoting best practice.
• Work effectively with allied methods groups including biostatistics to ensure join-up in approaches and efficiencies across data management and analysis. 

Main Responsibilities and Tasks

• Lead and oversee data management and information systems activities across NCTU to enable effective development and delivery of NCTU clinical trials and studies.

This will include line managing team members, overseeing day-to-day work, and maintaining a positive and cohesive work environment in order to maximise effective working across the unit’s multidisciplinary teams

Systems

• Lead and oversee the NCTU Clinical Data Management (CDMS) and randomisation systems, and other related systems as appropriate. Interact with system providers, University IT, IG and procurement team. 
• Act as the NCTU Information Governance Lead, with responsibility for the implementation, continuous review, improvement, and assessment of the systems for hosting NHS Digital or similar data, including leading and advising on the completion of Data Protection Impact Assessments (DPIA), and similar, as required.
• Responsible, with members of the senior team, for managing the appropriate sharing of trial and study data and secure and compliant data archiving within the unit.
• Proactively identify any issues relating to data, systems, and data management, finding and implement solutions.

Staff

• Manage the performance, training and professional development of the Data Management Team (DMT), allocating workload and ensuring the team produce compliant and effective systems in accordance with milestones.
• Provide oversight and development of the DMT to ensure timely data cleaning procedures, and quality controls that produce trial data which are accurate, complete and timely and ready for statistical analysis.
• Provide training to the DMT, wider unit, and its affiliates, as appropriate.
• Contribute to Unit activities as a member of the NCTU Senior Team.
• Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators, including Biostatisticians.

Unit Representation

• Represent the Unit in relation to data management, by establishing and maintaining internal and external links and engaging with stakeholders, attending internal and external meetings and conferences as appropriate.

Trial and Study Design and Delivery

• Provide high-level advice for new trials being developed in collaboration with NCTU, taking responsibility for advising trial teams regarding suitable data management procedures in compliance with all applicable regulatory requirements, including those for the use of secondary data.
• Contribute to resourcing, and management of trial and unit finances; forecasting data management needs for individual trials; liaising with the other members of the NCTU senior team to enable appropriate funding, financial transactions and reporting in line with contract(s).

Regulatory Requirements

• Lead on the continual development and review of NCTU data management processes including standard operating procedures (SOPs), to ensure they are compliant with the regulatory requirements and follow recognised best practice.
• Work with others in NCTU (including QA) to ensure processes are congruent across the unit.
• Keep up to date with latest developments and maintain a high level of professional knowledge in relevant areas, including regulatory requirements, CDMS developments, information governance, and access requirements for NHS Digital data.
• Take responsibility for regular monitoring of compliance with NCTU and data management procedures and other applicable requirements; coordinating data management inputs during audits, raising issues appropriately with senior colleagues and taking responsibility for any resulting training or process development needs identified including development of Corrective and Preventative Action (CAPA) plans.

To undertake such other reasonable duties as required by Head of Unit

The Person

Knowledge, Skills and Experience 

• Substantial experience of leading, managing and working in teams, with excellent teamwork skills
• Experience in change management and process improvement
• Able to work independently, and to make decisions on complex matters
• Proven leadership skills in a multi-stakeholder environment
• Substantial relevant data management experience relating to interventional clinical trials
• Substantial recent experience of the requirements, design, development and build of databases related to clinical research including off the shelf CDMS tools (e.g. Ennov, Medidata, MACRO, Red Pill, RedCAP)
• Advanced and recent working knowledge in systems, and software that support data collection, storage, analysis, and reporting, along with strong skills in effective use of Microsoft office tools including Excel and Word
• Very good working knowledge of one or more statistics packages (e.g. STATA, SAS, SPSS, R, Minitab)
• Substantial experience of clinical data management across the full trial lifecycle, and oversight of all data management activities, including development of documentation, query management, programming, data validation and liaison with trial and study teams including production of reports
• Substantial experience of developing and documenting new data management processes, polices, and SOPs
• Experience in line managing, supervising, mentoring/coaching, and managing performance of staff
• Thorough understanding of information governance, the requirements for hosting NHS Digital data, and the regulatory framework for data protection and management including GDPR
• Demonstrable knowledge of the regulatory framework for clinical trials (Good Clinical Practice, EU Clinical Trials Directive)
• A proactive approach with excellent organisational skills, and the ability to prioritise workload effectively whilst working across multiple projects and teams concurrently
• Broad understanding of clinical trials methodology
• Proven analytical and problem-solving skills
• Effective project management skills, ideally for Data Management or clinical research

       Desirable

• Experience of working in a University, Pharmaceutical Industry, or NHS environment
• An understanding of data collection in an NHS research environment
• Experience of managing data management staff

Attributes and Behaviour

• Excellent communication and interpersonal skills, with the ability to communicate and work effectively with staff at all levels
• Ability to motivate, negotiate and influence both individuals and teams
• Ability to handle sensitive and confidential issues and manage conflict effectively
• High degree of initiative, responsibility and self-motivation and a professional and proactive approach to problem solving
• Ability to define priorities and work flexibly and effectively under pressure to meet demanding (and sometimes conflicting) deadlines
• Willingness to learn new skills and procedures
• High levels of resilience
• Flexible team player willing to do what it takes to get the job done; adaptable and enjoys a challenge
• Excellent attention to detail
• Flexible approach to working
• Willingness to travel

Qualifications

• Degree in a relevant subject (a degree in a scientific, mathematical or statistical field is considered relevant) or equivalent significant professional experience

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. 

Requisition ID: 29118