Clinical Trials Manager (Maternity cover)

We are looking for a Trial Manager to join the Oxford Respiratory Trials Unit
for maternity leave cover. This post is also being offered as a 1 year
secondment opportunity. The Trial Manager will be responsible for planning and
overseeing the set up and management of a variety of studies 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 studies -
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 studies within the portfolio. This will include predicting,
identifying and resolving problems that are critical to the conduct of studies
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.





There will be opportunity for some hybrid office/remote working in line with
department guidance e.g one to two days at home depending on working
hours/pattern. The Unit has a core office day on a Thursday.





**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.





**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**





University employees enjoy 38 days’ paid holiday, generous pension schemes,
travel discounts, and a variety of professional development opportunities. Our
range of other employee benefits and discounts also includes free entry to the
Botanic Gardens and University colleges, and discounts at University museums.
See https://hr.admin.ox.ac.uk/staff-benefits





**Application Process**





Please contact Emma Hedley emma.hedley@ndm.ox.ac.uk or Ellie Daly
ellie.daly@ndm.ox.ac.uk for more details.





The post is full time and fixed term to cover maternity leave for 12 months
and is available from June 2025. This role can also be a secondment
opportunity.





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 Wednesday 2 April 2025 will
be considered.