Clinical Trial Manager - CCTU London, England
Job description
About us
The UCL Institute of Clinical Trials and Methodology
The Institute was established on 1 August 2013 and is formally comprised of two Research Departments: The MRC Clinical Trials Unit at UCL (MRC CTU) and the Comprehensive Clinical Trials Unit at UCL (CCTU). It currently directly employs 265 staff and generates an annual income in excess of £30 million. Over time, and building on the strengths of its Research Departments the mission of the Institute is to become a centre of excellence for the conduct of all phases of clinical trials, meta-analysis and epidemiological studies. Key areas of focus for the Institute will include delivering innovations in trial methodology, training and developing the next generation of trialists.
Comprehensive Clinical Trials Unit (CCTU)
The Comprehensive Clinical Trials Unit is a specialist unit set up within the Institute of Clinical Trials and Methodology with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies led by UCL Chief Investigators. The CCTU provides clinical, statistical and trial operations and facilitates the delivery of high quality, regulatory compliant clinical trials of investigational medicinal products (IMPs) and non-IMP trials. The CCTU is a registered CTU with the capability to centrally coordinate multi-centre clinical trials (i.e. having overall responsibility for the design, development, recruitment, data management and analysis of trials) with robust systems to ensure conduct and delivery of clinical trials to the highest quality standard.
About the role
Duties and responsibilities
- To establish and maintain effective management systems for the trial
- To act as the central Trials Unit contact for the Trial
- To work closely with the Chief Investigator, trial and IT staff to ensure the successful management of the Trial.
- Secure all necessary approvals for the trial and participating sites according to the UK regulations including UK Research Governance Framework
- Coordinate the design, printing and distribution of trial documentation
- Develop trial specific documentation that is compliant with the CCTU Policies and
- Standard Operating Procedures (SOPs) and ensure this is implemented and kept up to date.
- Ensure sites have appropriate training and maintain necessary records.
- Work within budget constraints in liaison with the Project Manager.
- Ensure that good communication is maintained between the CCTU and recruiting centre staff
- Provide updates on the progress of the trial at regular Trial Management Group meetings, to the Independent Data Monitoring and Trial Steering Committees and to the funder as required.
- Monitor the trial sites to assess compliance with the protocol and regulatory requirements.
- Prepare under the guidance of the Clinical Project Manager, the trial specifications for the Database.
- Undertake Risk Assessment of the trial and, with the Clinical Project Manager, propose appropriate mitigations.
- Minute trial related meetings.
- Supervise the data collected and enter data if required.
- Supervise the data cleaning and validation, including querying and chasing missing data in a timely manner.
- Monitor trial recruitment, providing support and motivation to recruiting staff as required.
- Ensure the timely submission and processing of data and documents from sites to the CTU including safety events. Prepare and submit the necessary reports to appropriate regulatory, ethical and other parties (such as submission of safety reports to the Ethics Committee).
- Represent the trial at conferences, meetings and internal unit meetings as appropriate.
- Keep the relevant literature searches up to date.
- Participate in UCL and the CCTU training and development initiatives.
- Carry out any other comparable tasks as required including being prepared to assist those working on other studies/trials as directed by the Head of Clinical Trial Operations.
About you
An enthusiastic, committed and professional individual is sought for this post, which is based in Holborn, London.
The successful applicant must possess a degree and/or equivalent experience in Clinical Trials, as well as a comprehensive understanding of UK Clinical Trials Regulations, the European Directives on Clinical Trials and Good Clinical Practice and the Department of Health’s Research Governance Framework.
We are looking for someone with good scientific and clinical trial acknowledge. An ideal candidate would possess on-site monitoring experience, good communication skills, an ability to work within a multi-disciplinary team, experience of study trial documentation development, excellent attention to detail and organisational skills and a willingness to travel within the UK and/or internationally.
An experience of Line Management would be advantageous, however is not essential.
Job share candidates will be considered.
Previous applicants need not apply.
What we offer
As well as the exciting opportunities this role presents, we also offer some great benefits some of which are below:
- 41 Days holiday (including 27 days annual leave 8 bank holiday and 6 closure days)
- Hybrid Final Salary Pension Scheme,
- Cycle to work scheme, and season ticket loan,
- On-site gym, Enhanced maternity, paternity and adoption pay,
- Employee assistance programme: Staff Support Service,
- Discounted medical insurance.
To apply please click on the ‘Apply Now’ button below. Further information about the Institute is available via the CTU at UCL website: www.ucl.ac.uk/comprehensive-clinical-trials-unit.
If you have any queries regarding the vacancy or the application process, to arrange an informal discussion regarding the post please contact CCTU Enquiries ([email protected]).
Our commitment to Equality, Diversity and Inclusion
As London’s Global University, we know diversity fosters creativity and innovation, and we want our community to represent the diversity of the world’s talent. We are committed to equality of opportunity, to being fair and inclusive, and to being a place where we all belong. We therefore particularly encourage applications from candidates who are likely to be underrepresented in UCL’s workforce. These include people from Black, Asian and ethnic minority backgrounds; disabled people; LGBTQI+ people; and for our Grade 9 and 10 roles, women. You can read more about our commitment to Equality, Diversity and Inclusion here : https://www.ucl.ac.uk/equality-diversity-inclusion.
