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Clinical Trial Manager

2 months ago

Southampton, United Kingdom University of Southampton Full time

Applications are invited for a Clinical Trial Manager to join Professor Andrew Lotery’s existing vision science research team to undertake a leading role in an ongoing, fully funded observational clinical trial: “Deciphering age related macular degeneration (AMD) by deep phenotyping and machine learning (The PINNACLE study)”. This is a “big data” study utilising artificial intelligence to help understand the commonest cause of blindness in the Developed World.

The vacancy is an exciting opportunity for an established Trial Manager, or someone with proven equivalent skills and experience, to join the existing team as the primary point of contact for the multi-centre PINNACLE trial (2019 to 2025) as well as the newly awarded PINNACLE follow-on trial called SUMMIT (2024 to 2027). 

The successful applicant will have significant clinical trials experience in the NHS, commercial health research sector or clinical academic research.. They will be highly motivated, capable of pro-active, independent working and have excellent organisational and communication skills.  Previous experience using electronic data capture (EDC) systems, ISF and/or TMF management, handling large amounts of trial related data, and knowledge of study protocols are a must. The position requires excellent stakeholder engagement, with effective communication with study sites within the UK and Europe, collaborating institutions, data management representatives and regulatory bodies, amongst others, forming a large part of the role. Proficient  understanding, knowledge and experience of GCP, clinical trial regulations is essential. Ideally, your GCP certification will be active currently. 

A hybrid working pattern is possible, with 1 or more days a week being office based at University Hospital Southampton (formerly Southampton General Hospital). There is a requirement for occasional travel within the UK for trial meetings.

Andrew Lotery is Professor of Ophthalmology at the University of Southampton and leads several ophthalmic clinical trials, including the PINNACLE Trial (and SUMMIT follow-on trial) investigating the role of biomarkers in identifying the early stages of AMD. The Vision Sciences research group is part of a strong research environment in Southampton, within Clinical and Experimental Sciences liaising with the Wellcome Trust Clinical Research Facility and NHS R&D. In addition, the wider group’s focus is on understanding the basic mechanisms of this disease and to develop disease specific therapies in order to improve vision. 

The employing organisation is the University of Southampton which offers a competitive salary, pension scheme and other benefits.  The post is offered as a full-time, fixed term contract for just over 3 years, with an expected end date of 31/12/2027.

For an informal discussion about this post please contact: Professor Andrew Lotery A.J.Lotery@soton.ac.uk or Senior Research Manager, Ms Angela Cree A.J.Cree@soton.ac.uk

£34,980 to £42,978 per annum