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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.

 

 

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

 

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.

 

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 27/02/2024 will be considered.

 

Previous Applicants Need Not Apply

 
"""^^ . . "site principal"@fr . . . "Agent" . "2024-02-06T14:15:00+00:00"^^ . _:Ne043c50ec3044c38baa8c02c7996024e "OX3 9DU" . . . "depiction" . "Title"@en . "text/plain" . . _:Ne043c50ec3044c38baa8c02c7996024e "United Kingdom" . """ **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. **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** 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. 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 27/02/2024 will be considered. **_Previous Applicants Need Not Apply_** """ . "way/24615604" . _:N0ab57571cdb74e1c86fc42fcc1105ea3 "OX3 7LE" . "Unit price specification"@en . . _:N60939b63ab344ca4a60464ce94f2bf3a "+44-1865-270708" . . _:N954354a7d2dc4617b6c3fac56125c0bf . . . . "EXPMED" . "00000000"^^ . "subOrganization of"@en . . . "Fax"@en . . "Churchill OCDEM 1" . . . . "text/n3" . _:N0ab57571cdb74e1c86fc42fcc1105ea3 "Oxford" . _:N0ab57571cdb74e1c86fc42fcc1105ea3 "Churchill Hospital, Old Road" . "Standard Grade 7: £36,024 - £44,263 per annum (pro rata for part time)" . "false"^^ . . . . . . . "has exact match"@en . "sede principale"@it . "RDF/XML description of Clinical Trials Manager" . . "valid through (0..1)"@en . _:N60939b63ab344ca4a60464ce94f2bf3a . 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