Clinical Trials Manager

**About the Role**





We are looking for a Clinical Trial Manager to join the Oxford Respiratory
Trials Unit. The Clinical Trial Manager will be responsible for planning and
overseeing the set up and management of a variety of trials conducted at ORTU
and providing support to the Senior Trial Manager. This post requires someone
who can work both as a member of a multi-disciplinary team and independently,
using their initiative to seek solutions to problems and provide excellent
administrative support.





You will be responsible for the day-to-day management of ORTU clinical trials
- supporting Chief Investigators, Trial Assistants and Assistant Trial
Managers in applying for regulatory approvals for trials including MHRA,
ethics, HRA and Research & Development (R&D) approvals. You will also be
responsible for organising team meetings, answering and resolving queries on
trial conduct.





In this post you will maintain oversight of the overall conduct and
performance of trials within the portfolio. This will include predicting,
identifying and resolving problems that are critical to the conduct of trials
managed by the ORTU and planning to strategically avoid them. You will also
have the opportunity contribute to the CTU quality management system,
reviewing and writing SOPs and developing procedural documentation, as
applicable.








**About You**





Applicants should be educated to degree level in a relevant subject or have
considerable experience in the set-up and ongoing monitoring and management of
large complex multi-site clinical trials.





You will also need to demonstrate that you have:





• Good communication skills (oral and written), confident and articulate, and
able to work across professional team and organisational boundaries to deliver
training and work well with staff at all levels.



• A range of IT skills (Word, Excel, PowerPoint, Outlook,) as demonstrated in
part by your application.



• Experience of writing Standard Operating Procedures, Trial Specific
Procedures and working within a Quality Management System.



• Experience of planning and progressing work activities using own initiative
without supervision, prioritising own schedule and that of others, dividing
time between projects appropriately.



• Thorough knowledge of the regulatory and governance requirements for UK
clinical trials – including submission of applications to these bodies.





Having had previous experience in a respiratory trial setting and experience
of CTIMP and Device Trials are both desirable capabilities for this post.





If you are interested in this opportunity or would like to arrange an informal
visit to the unit, please get in touch with our Senior Clinical Trials
Manager, Emma Hedley via emma.hedley@ndm.ox.ac.uk or 01865 282952.








**About the Nuffield Department of Clinical Medicine**





The Nuffield Department of Clinical Medicine (NDM) is one of the largest
departments of the University of Oxford and is part of the Medical Sciences
Division, with responsibility for a significant part of the teaching of
clinical students within the Medical School.








**Benefits of working**





Employee benefits – 38 days’ paid holiday, generous pension schemes, travel
discounts, a variety of professional development opportunities, including
yearly salary increments.





University club and sports facilities - Membership of the University Club is
free for all University staff. The University Club offers social, sporting,
and hospitality facilities.





Family-friendly benefits - With one of the most generous family leave schemes
in the Higher Education sector, and a range of flexible working options,
Oxford aims to be a family-friendly employer. We also subscribe to the
Work+Family Space, a service that provides practical advice and support for
employees who have caring responsibilities. The service offers a free
telephone advice line, and the ability to book emergency back-up care for
children, adult dependents and elderly relatives.








**Application Process**





The post is part-time 0.7 – 0.8 FTE (26.25 – 30 hours per week) and fixed-term
for 12 months in the first instance.





There will be an opportunity for hybrid working in line with department
guidance.





Applications for this vacancy are to be made online. You will be required to
upload a supporting statement and CV as part of your online application.





Only applications received before 12:00 midday on 03/04/2024 will be
considered.





**_Previous Applicants Need Not Apply_**