Job summary
The Cancer Clinical Trials Unit at UCLH is looking to recruit a Data Manager on a 12-month fixed term contract to cover maternity leave, to support a portfolio of Phase I-III clinical trials in the Paediatric/TYA team. You may be required to cover other disease areas on a short-term or longer term basis.
The post-holder will be required to deliver and verify trial-specific information to sponsors, support the team with the set-up of new clinical trials and assist as needed with the processing of biological samples, amongst other tasks. You will be part of supportive and dynamic team, working closely with clinical research staff. Whilst the position is administrative, the role is vital in supporting clinical research staff deliver excellent care to patients with cancer.
We are currently supporting hybrid remote working, allowing a combination of working from home and office-based working. Flexibility around on-site working is essential and you may be required to attend the office at relatively short notice to ensure that the service is covered.
We ideally want someone with experience of clinical research, knowledge of cancer, good verbal and written communication skills and some experience of working in a healthcare setting. However, if you have some of these criteria and clear enthusiasm for the role, then please apply.
For further information please contact Tara Searle, Senior Research Nurse and Team Lead, tara.searle@nhs.net
Main duties of the job
The post holder will:
- Have a portfolio of trials for which they are responsible
- Complete data entry into case report forms for assigned trials as per protocols
- Ensure case report forms are completed are of high quality, accurate and sent in a timely manner
- Resolve issues with source data and anomalous data at the time of reporting, reviewing against previously reported data as well as local and national normal ranges.
- Prioritises workload to manage time effectively
- Process updated information and documents for the successful running of the study
- Create and maintain both paper and electronic trial site files
- Maintain list/database of up-coming, current and recently closed clinical trials
- Maintain electronic and paper list of accrual to trials
- Organise and prepare documentation for audits and monitoring visits.
- Process biological samples in the trials lab
- Liaise with the MDT, Principal and Sub Investigators, Sponsors, and support departments professionally and appropriately
- Obtain tumour block samples
- Upload scans as required by trial protocol
- Escalate issues to senior team members
The portfolio is very diverse, with a wide range of studies, to reflect the varied nature of the disease area in this age group. The successful applicant should be organised, pro-active and able to work autonomously, while also collaborating and communicating with the rest of the trials team and the doctor. Full duties are explained in the attached job description.
About us
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.
We provide first-class acute and specialist services across eight sites:
- University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
- National Hospital for Neurology and Neurosurgery
- Royal National ENT and Eastman Dental Hospitals
- University College Hospital Grafton Way Building
- Royal London Hospital for Integrated Medicine
- University College Hospital Macmillan Cancer Centre
- The Hospital for Tropical Diseases
- University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.
Job description
Job responsibilities
The Cancer Clinical Trials Unit office is based in 250 Euston Rd and comprises of three main areas: Haematology, Oncology and Complex Pathways and it supports activity in the local Clinical Research Facility and the North Thames Local Comprehensive Research Network and Experimental Cancer Centre. Each group is comprised of teams of research nurses, clinical trial practitioners and data managers and provides support to local Investigators wishing to conduct clinical trials and other high quality clinical research projects within UCLH. Each team supports a process for agreeing a portfolio of research and ensures that trials are conducted to the highest standards and in accordance with UK legislation and the R&D Governance Framework. The aim of the Unit is to effectively use resources so as to ensure that patients have access to entry into clinical trials, as appropriate, and maintain the highest quality of care for patients.
Cancer Services sits within the Surgery and Cancer Board. It incorporates comprehensive outpatient, day care, and ambulatory care and inpatient services for the specialities of inpatient and outpatient oncology and Haematology.
For more information regarding the main responsibilities of the role, please refer to the attached Job Description
Job description
Job responsibilities
The Cancer Clinical Trials Unit office is based in 250 Euston Rd and comprises of three main areas: Haematology, Oncology and Complex Pathways and it supports activity in the local Clinical Research Facility and the North Thames Local Comprehensive Research Network and Experimental Cancer Centre. Each group is comprised of teams of research nurses, clinical trial practitioners and data managers and provides support to local Investigators wishing to conduct clinical trials and other high quality clinical research projects within UCLH. Each team supports a process for agreeing a portfolio of research and ensures that trials are conducted to the highest standards and in accordance with UK legislation and the R&D Governance Framework. The aim of the Unit is to effectively use resources so as to ensure that patients have access to entry into clinical trials, as appropriate, and maintain the highest quality of care for patients.
Cancer Services sits within the Surgery and Cancer Board. It incorporates comprehensive outpatient, day care, and ambulatory care and inpatient services for the specialities of inpatient and outpatient oncology and Haematology.
For more information regarding the main responsibilities of the role, please refer to the attached Job Description
Person Specification
Knowledge & Qualifications
Essential
- Life Science degree
- Knowledge of drug development process and concept of clinical trials
- Knowledge of ICH GCP
Desirable
- Knowledge of oncology and/or haematology
Experience
Essential
- Experience of working under minimal supervision
- Experience of working as part of large teams
- Experience of working to deadlines
- Experience of independently carrying out a research project
Desirable
- Experience of conducting clinical trials
Skills & Abilities
Essential
- Proven ability to work under own initiative
- Computer literacy to include experience of Word & Excel
Desirable
- Knowledge of ICH GCP
- Knowledge of oncology and/or haematology
Personal Qualities
Essential
- Proven ability to communicate effectively in writing
- Good eye for detail
- Ability to identify own training needs
- Displays desire for professional and personal development
Person Specification
Knowledge & Qualifications
Essential
- Life Science degree
- Knowledge of drug development process and concept of clinical trials
- Knowledge of ICH GCP
Desirable
- Knowledge of oncology and/or haematology
Experience
Essential
- Experience of working under minimal supervision
- Experience of working as part of large teams
- Experience of working to deadlines
- Experience of independently carrying out a research project
Desirable
- Experience of conducting clinical trials
Skills & Abilities
Essential
- Proven ability to work under own initiative
- Computer literacy to include experience of Word & Excel
Desirable
- Knowledge of ICH GCP
- Knowledge of oncology and/or haematology
Personal Qualities
Essential
- Proven ability to communicate effectively in writing
- Good eye for detail
- Ability to identify own training needs
- Displays desire for professional and personal development
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
