Job Description
Main area Clinical Trials Grade Band 8a Contract 24 months (Fixed Term for 24 months) Hours
- Full time
- Part time
- Flexible working
Employer Cambridge University Hospitals NHS Foundation Trust Employer type NHS Site Addenbrookes Hospital-Division Corporate Town Cambridge Salary £50,952 - £57,349 p.a. pro rata Salary period Yearly Closing 27/06/2024 23:59
Job overview
The Cambridge Clinical Trials Unit (CCTU) is part of the NIHR UKCRC Registered CTU Network with the remit to provide support for all aspects of clinical trials from set-up to close down within the Cambridge Biomedical Research Centre.
Applications are invited for the post of Clinical Trials Manager in the CCTU which provides support for clinical trials within the Biomedical Research Centre. The post is based within the CCTU Core and Cardiovascular Themes.
The Clinical Trials Manager will work in partnership with the CCTU Operations Director, Senior CCTU staff and members of individual trial teams to ensure the smooth and efficient conceptualisation, set-up, delivery and reporting of trials that are led and run by CCTU. On a daily basis, lead project management for trials under their remit and ensure that staff follow relevant CCTU SOPs, CUH policies and UK Regulations.
Previous experience of working in a clinical research environment within the NHS, University or pharmaceutical industry is essential for this post together with significant knowledge and experience of UK regulations, guidelines and requirements for the conduct of clinical research. Project management experience, as well as understanding of advanced therapy and device trials would be advantageous.
Main duties of the job
To lead clinical trial project management for designated trials within CCTU, including interaction and work flow between key CCTU staff involved in trial delivery e.g. coordination, data management, statistics, QA, Investigators and the trial management group.
Develop the CCTU clinical trials coordination and trial management function under the direction of the CCTU Operations Director and CCTU Director/Theme Director across Core and Cardiovascular trials.
To advise researchers on trial design, feasibility, trial management costs and approvals and processes.
To maintain oversight of trial set-up, delivery and reporting and provide project management for the financial aspects of the trial activity.
To ensure that all GCP and other statutory requirements are met during the conduct and coordination of these clinical trials.
Working for our organisation
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke’s Hospital and the Rosie Hospital in Cambridge. With over 11000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people – patients, staff and partners. Recognised as providing ‘outstanding’ care to our patients and rated ‘Good’ overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH’s values – Together - Safe, Kind, Excellent – are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people’s age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Detailed job description and main responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 28th June 2024.
Interview date to be confirmed.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person specification
Qualifications
- Relevant science postgraduate qualification or equivalent.
- Research related qualification, for example Epidemiology based Master degree or similar.
Experience
- Extensive staff line management experience. Extensive experience in set-up, managing and coordination of Clinical Trials. Managing a team of clinical trial coordinators and data managers. Extensive experience of UK regulations on clinical trials. Writing protocols, grant applications. Identification of research cost associated with clinical trials; costing for grant applications, submissions of MHRA/Ethics/HRA applications. IMP management and requirements. Sample management and human tissue act requirements.
- Extensive experience in set-up, managing and coordination of Clinical Trials.
- Managing a team of clinical trial coordinators and data managers.
- Extensive experience of UK regulations on clinical trials.
- Identification of research cost associated with clinical trials; costing for grant applications.
- Submissions of MHRA / Ethics / HRA applications.
- IMP management and requirements.
- Experience of advanced therapy trials, and/or medical devices and/or epidemiological studies.
- Working in the NHS/ University research environement with consultants and academic investigators.
- Project management, ability determine mile stones and realistic time lines.
- R & D/University research contract negotiations.
- CRF design and data base requirements.
Knowledge
- Good Clinical Practice.
- EU Clinical Trials Directive.
- Funding for academic research.
- Process of grant applications.
Skills
- Excellent organisational and communication skills. Good workload management. Ability to liaise with a wide range of staff, including principal investigators and their teams. Ability to communicate complex regulatory issues in a clear and logic way. Fully Computer Literate and Experience with using trial databases. Experience in producing and presenting reports, including financial report. Ability to present data in clear and simple format.
- Ability to liaise with a wide range of staff, including principal investigators and their teams.
- Ability to communicate complex regulatory issues in a clear and logic way.
- Fully Computer Literate and Experience with using trial databases.
- Experience in producing and presenting reports, including financial report.
- Ability to present data in clear and simple format.
- High level of computer literacy.
- Use of specialist IT programmes like MACRO, ReDa, QPulse.
- Recruitment, selection and appraisal skills.
Additional Requirements
- Ability to work and lead a team.
- Able to use own initiative and under pressure.
- Able to keep up to date with legal and ethical, scientific requirement for clinical research.
- Understanding of the need for and principles of accurate and timely data collection and reporting.
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Understanding the needs of research active investigators from NHS Trust and University.