Location
London

Hours
Full Time

Salary
£33,094 per annum

About the Role
Guy’s and St Thomas’ NHS Foundation Trust is one of the UK’s busiest and most successful NHS trusts, providing a full range of hospital and community services across south London and specialist care nationally. The Oncology and Haematology Clinical Trials Team at Guy’s Hospital is seeking two Data Managers (Roving and Urology Team) to join their dedicated team. This role involves working closely with clinical teams, researchers, and IT personnel to ensure high quality data management in compliance with GCP, MHRA regulations, and institutional SOPs. Responsibilities include maintaining Investigator Site Files, managing trial documentation, verifying source data, and preparing for audits and monitoring visits. The post holder will support multiple research teams or work within the Urology Research team to facilitate accurate data collection, secure data handling, and efficient trial management.

Guy’s and St Thomas’ NHS Foundation Trust comprises five major hospitals and community services, renowned for clinical excellence, research, and innovation. The Oncology and Haematology Clinical Trials team manages a large portfolio of Phase II and III trials, including early phase trials, commercial and non-commercial studies, ranging from interventional drug or radiotherapy trials to observational studies. The team’s mission is to improve treatment choice, clinical care, and outcomes for cancer patients through innovation, dedication, and excellence in clinical trials.

Main Duties
- Liaise with clinical teams to ensure trial-specific investigations are conducted according to protocol and results obtained
- Maintain confidentiality of all verbal, written, and computerized information
- Manage trials in accordance with all regulatory requirements including SOPs, GCP, European Directives, Medicines for Human Use Regulations, Research Governance Framework, and Human Tissue Act
- Complete case report forms accurately and timely, ensuring clinical data is transcribed correctly
- Maintain Investigator Site Files and essential documentation with version control
- Assist in office system maintenance for smooth service operation
- Process amendments promptly according to SOPs
- Conduct source data verification and quality control
- Address data queries efficiently
- Prepare documentation for audits and monitoring visits
- Organise and record minutes for research and departmental meetings
- Develop the role to meet changing service requirements
- Provide data management training and identify personal training needs
- Attend national and international investigator meetings and conferences as required
- Collaborate with Quality Manager to update and implement SOPs
- Provide advice and training on data management within the team
- Communicate complex information with data suppliers, researchers, and IT teams
- Escalate data collection issues appropriately
- Create, validate, maintain, and secure databases ensuring compliance with data protection legislation
- Enter patient data accurately and efficiently
- Generate reports from databases for researchers
- Extract and transcribe patient medical record information confidentially
- Support audit and survey work
- Work independently with initiative and seek advice as needed

Experience
- Experience handling confidential information
- Experience working in a team environment
- Experience using databases and entering data accurately
- Experience with software and computer systems related to data queries and database building
- Desirable: Experience in NHS and oncology settings

About you
- Ability to communicate effectively within a multidisciplinary team
- Excellent organisational, presentation, and communication skills
- Ability to manage priorities under pressure
- Strong IT skills, specifically in database management and MS Office
- Accurate data entry and excellent analytical skills
- Knowledge of research methodologies
- Desirable: Knowledge of mandatory standards for clinical research conduct (including GCP, UK Policy framework for Health and Social Care research, data protection)
- Ability to use hospital databases such as EPR
- Ability to assess and interpret clinical and non-clinical information to determine appropriate actions
- Able to concentrate for prolonged periods when cross-referencing medical case notes
- Initiative and enthusiasm to maintain a high professional standard in a busy department
- Ability to work independently without direct supervision
- Ability to prioritise tasks and work accurately
- Proactive and able to propose and implement new administrative procedures
- Flexible and positive approach to work

Qualifications
- Essential: NVQ level 4 or equivalent qualification, or NVQ level 3 plus significant relevant experience
- Desirable: Degree or equivalent qualification
- Good Clinical Practice (GCP) training is desirable