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 [email protected] 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