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Quality Assurance Manager

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

Location: Exeter
Salary: The starting salary will be from £44,706 on Grade G, depending on qualifications and experience.
Hours: Full Time
Contract Type: Permanent
Placed On: 24th August 2021
Closes: 20th September 2021
Job Ref: S75221

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.

Further information
Please contact Siobhan Creanor, E.S.Creanor@exeter.ac.uk.

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