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Senior Clinical Project Manager

UCL Institute of Neurology - Department of Clinical and Experimental Epilepsy

Location: London
Salary: £44,674 to £52,701 per annum (including London Allowance), Grade 8
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 14th January 2020
Closes: 3rd February 2020
Job Ref: 1857672

UCL Queen Square Institute of Neurology 

Applications are invited for a Senior Clinical Trial Manager in the Department of Clinical and Experimental Epilepsy, UCL Queen Square Institute of Neurology, under the supervision of Prof Stephanie Schorge and Prof Matthew Walker.

This position is to develop and manage a clinical trial for the Epilepsy Gene Therapy group based in the Department of Clinical and Experimental Epilepsy, and requires independent working as well as excellent communication skills to enable the trial. This is an excellent opportunity to work at the interface between experimental and clinical research, and interact with inter-disciplinary groups developing advanced therapies for a range of neurological diseases.  

You will be responsible for establishing and implementing the operational elements of the first phase I/II gene therapy clinical trial for focal drug-resistant epilepsy. You will ensure the successful delivery of the study, working closely with and advising the Chief investigator, trial team and the trial site and sponsor.  The duties include (but are not limited to) writing/reviewing all essential documents, and preparing and submitting CTAs/amendments to MHRA, ethics committees and local R&D offices. You will also be responsible for data management, maintaining the Trial Master File, contributing to writing annual progress reports, DSURs, clinical study reports, managing budgets and organising various trial committees.  You will ensure that the clinical trial is conducted in line with the protocols, GCP and all regulatory requirements. Where required, you will also coordinate preparation and submission of Orphan Drug Designation Applications and requests for protocol assistance, scientific advice to the European Medicines Agency. 

Because of the independence of this position, applicants must have expertise in managing clinical trials Investigational Medicinal Products (IMPs) and experience in preparation and submission of MHRA/ethics applications and amendments. Data management expertise, experience in liaising with the MHRA, REC and local R&D offices and safety recording and reporting are also required. A very high level of consideration and care for patients and research subjects and excellent interpersonal skills to facilitate liaison with colleagues and trial collaborators are essential. Expertise in managing clinical trials of Advanced Therapy Investigational Medicinal Products(ATIMPs), gene or cell therapy, molecular biology or immunology and experience liaising with the EMA are desirable.

The post is available from 6 January 2020 and is funded by a grant from MRC until 31 August 2022 in the first instance. The post is graded as Grade 8, the salary for which ranges from £44,674 to £52,701 per annum (including London Allowance). 

You should apply for this post through UCL's online recruitment – www.ucl.ac.uk/hr/jobs where you can download a job description and person specification using ref: 1857672. 

If you have any queries regarding the application process, please contact Oksana Shapoval, HR Officer, UCL Queen Square Institute of Neurology (email: ion.hradmin@ucl.ac.uk).    

Informal inquiries can be made to Professor Stephanie Schorge (email: s.schorge@ucl.ac.uk). 

We particularly welcome applications from black and minority ethnic candidates as they are under-represented within UCL at this level. 

We will consider applications to work on a part-time, flexible and job share basis wherever possible.

   
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