The Southampton Clinical Trials Unit (SCTU)
usually based at Southampton General Hospital, manages a growing portfolio of multi-centre clinical trials that will directly influence routine clinical practice. At the current time CTU staff are mainly working from home, due to the pandemic; the appointed candidate should therefore be prepared to work from home until we are allowed back into the CTU offices.
We have a vacancy for a Quality Manager to join the Quality, Pharmacovigilance and Monitoring team. This is an exciting opportunity for someone with previous quality management experience in clinical trials, to join a CTU, which has full registration status from the UK Clinical Research Collaboration (UKCRC). The successful candidate will be appointed at level 4.
The successful applicant will ideally have experience of working in a quality management role, on clinical trials within the NHS, academic or commercial health research sector. The successful applicant will also have excellent organisation and communication skills, a good understanding and knowledge of Good Clinical Practice (GCP) and clinical trial regulations. The post holder will be expected to manage the internal and external audit programme and to act as audit lead for the unit. Experience in administering Q-Pulse or a similar document system would be desirable.
Occasional travel to perform vendor audits will be required for this role.
The employing organisation is the University of Southampton which offers a competitive salary, pension scheme and other benefits. The post is offered on a 24 months fixed term contract in the first instance with the possibility of an extension. This is a full-time post but part time 0.8FTE may be considered.
The CTU is part of a strong research environment in Southampton which includes the Cancer Research UK Clinical Centre, Experimental Cancer Medicine Centre, Clinical Research Facility and NHS R&D Management.
For an informal discussion about this post please contact Sara Yeats; s.a.yeats@southampton.ac.uk
Application Procedure
You should submit your completed online application form at https://jobs.soton.ac.uk. The application deadline will be midnight on the closing date stated above. If you need any assistance, please call Dan Ward (Recruitment Team) on +44 (0) 23 8059 7749 or email recruitment@soton.ac.uk Please quote reference 1295220CM on all correspondence.