• Full Time
  • Anywhere

College Operations (College of Medicine & Health, Exeter Clinical Trials Unit ExeCTU)

This full time post is available immediately on a permanent basis.

Summary of the role

Exeter CTU is a rapidly growing UKCRC-registered unit. Our experienced staff work in partnership with researchers and clinicians across the trial lifecycle to design, conduct and publish high-quality clinical trials and other well-designed studies. Our growing portfolio includes dementia, mental health, orthopaedics, diabetes, emergency medicine and Covid-19, supported by funding from the NIHR, UKRI, Horizon2020, large charities and others. Multi-centre studies include regulated drug trials, surgical, device and apps trials and trials of complex interventions, locally in the South West, nationally and internationally

The role

An exciting opportunity has arisen for a Quality Assurance Manager to play the lead role within the Quality Assurance (QA) development of the Exeter CTU. The QA Manager will work as part of the Senior Management and Operations Teams with overall responsibility for the quality management systems and quality assurance processes.

The post holder will take a strategic role in ensuring that projects comply with research and data regulations, e.g. Good Clinical Practice, the UK Medicines for Human Use (Clinical Trials) Regulations, the NHS Research Governance Framework, the Data Protection Act, Information Governance best practices, and UK Clinical Research Collaboration (UKCRC) requirements for CTUs. They will be expected to represent the CTU both nationally and internationally where required. 

This pivotal post requires frequent communication with researchers and other stakeholders at all levels and requires an experienced Quality Assurance Manager with a track record of providing sound regulatory advice, managing multiple complex initiatives. Experience of undertaking both internal and external audits is essential.

About you

We are ideally looking for an experienced Quality Assurance Managers that has:

  • Excellent knowledge of GCP and UK clinical trials regulations and substantial working knowledge of clinical trials in all phases
  • Substantial experience of conducting and reporting Clinical Trial Audits, including CSV, GCP and Monitoring.
  • Experience of managing and implementing quality control, quality assurance and quality management systems, ideally within a clinical trials unit setting
  • Experience of writing and implementing SOPs
  • Experience of working with CTIMP studies
  • Ability to give measured, pragmatic and expert GCP advice
  • Willingness to contribute to national or international networks
  • Please ensure you read the Job Description and Person Specification for full details of this role by clicking on the attachment above.

    The University of Exeter

    We are a member of the prestigious Russell Group of research-intensive universities and in the top 150 universities in the world (Times Higher Education World University Rankings 2019). We combine world-class teaching with world-class research, achieving a Gold rating in the Teaching Excellence Framework Award 2017.

    Our research income in recent years means we’re fastest growing UK Research University and we seek to answer some of the most fundamental issues facing humankind today through this. 98% of our research is international quality (2014 Research Excellence Framework) and we encourage proactive engagement with industry, business and community partners to enhance the impact of research and education and improve the employability of our students. Exeter is one of only a few UK cities to have been designated as a UNESCO Creative City.

    With over 27,000 students and 6,400 staff from 180 different countries we offer a diverse and engaging environment in which to work. We are an equal opportunity employer, a Disability Confident employer and an Athena Swan accredited institution. Since 2019, the university has also signed an Armed Forces Covenant, demonstrating the University’s commitment to supporting the Armed Forces community. Whilst all applicants will be judged on merit alone, we particularly welcome applications from groups currently underrepresented in the workforce.

    Benefits

    We offer some fantastic benefits including: 

  • 41 days leave per year
  • options for flexible working
  • numerous discounts at leading retailers
  • onsite gyms on all of our campus’ and a cycle to work scheme
  • sector leading policies around maternity, adoption and shared parental leave (up to 26 weeks full pay), paternity leave (up to six weeks full pay) and a new Fertility Treatment Policy
  • stunning campus environments in Exeter and Cornwall, in the beautiful South West of England
  • Further information

    Apply For This Job

    You can apply for this job externally via the button below.

    Apply for this job externally