Clinical Trial Manager - CCTU

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. The Institute also has two further units that are virtual members: The Cancer Research UK & UCL Cancer Trials Centre and the PRIMENT Clinical Trials Unit. 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. This job description reflects the present requirements of the post, and as duties and responsibilities change/develop, the job description will be reviewed and be subject to amendment in consultation with the post holder. In carrying out the above duties, the appointee is expected to adhere to UCL policies including Financial Regulations. The appointee will be expected to carry out any additional duties as may reasonably be required within the general scope and level of the post.

About you

An enthusiastic, committed and professional individual is sought for this post, which is based in Holborn, London. The primary role of the post holder is to set up and support a high quality clinical trial at the CCTU. The post holder will be responsible to a CCTU Clinical Project Manager. 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.

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. Please note that we are unable to support visa sponsorship for this role. A job description and person specification can be accessed at the bottom of this page. To apply please click on the ‘Apply Now’ button below. Further information about the Institute is available via the MRC 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 (cctu-enquiries@ucl.ac.uk).

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/