Clinical Trial Manager

University of Oxford; Oxford; Sur place; GBP 39 000 - 48 000; Plein temps

Résumé du poste

The University of Oxford is seeking a Trial Manager to take overall responsibility for the day-to-day management of multi-centre randomised clinical trials, based at the John Radcliffe Hospital in Oxford. You will help finalise the protocol, study materials, training packages and trial manuals, and work with the trial statistician and programmer on data collection and database testing.

A biomedical degree or equivalent experience is required.

Qualifications

• Degree in biomedical or related subject or proven experience in clinical research.
• Experience overseeing multi-centre clinical trials and working to Good Clinical Practice.
• Experience with medical data management and development of clinical reporting forms (REDCap desirable).

Responsabilités

• Manage day-to-day operations of multi-centre randomised trials.
• Finalize protocol, study materials, training packages and trial manuals.
• Collaborate with trial statistician and programmer on data collection and database testing.
• Obtain/maintain ethics and R&D approvals and ensure trial agreements are in place.
• Provide line management and training for administrative trial staff.

Connaissances

Trial management

Good Clinical Practice

Data management

REDCap

Formation

Biomedical degree or equivalent qualification

Outils

REDCap

Description du poste

This is a full time (part-time at minimum of 80% FTE will be considered), fixed term position for 3 years.

The University of Oxford is a stimulating work environment, which enjoys an international reputation as a world-class centre of excellence. Our research plays a key role in tackling many global challenges, from reducing our carbon emissions to developing vaccines during a pandemic.

The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) is part of the Medical Sciences Division and is the largest European academic department in its field, running a globally competitive programme of research and teaching. The Kadoorie Institute of Trauma, Emergency and Critical Care brings together interdisciplinary research across trauma and rehabilitation, emergency care and critical care, with a focus on improving outcomes for patients with life-threatening illness and injury. The Institute integrates expertise across these closely connected specialties within a single research environment. Based at the John Radcliffe Hospital, the centre of urgent and emergency care in Oxford, the Institute supports more than 100 multidisciplinary researchers working across the breadth of trauma, emergency and critical care research. Its research spans the use of routinely collected healthcare data and early- and late-phase clinical trials, enabling discoveries to be translated into improvements in clinical practice and patient care.

About the Role

In this role, you will work autonomously as a Trial Manager, taking overall responsibility for the day-to-day management of multi-centre randomised clinical trials. You will assist in finalising the protocol, study materials, training packages for collaborating sites and trial manuals, and prepare trial specific instructions. You will work to design data collection forms and associated documentation as required in collaboration with the trial statistician and Chief Investigator – then work with the trial programmer to assist in the design and testing of the trial database systems for randomisation, data entry, validation and report generation. This post involves obtaining and maintaining overall and site-specific ethical and R&D approvals for all sites and ensure Clinical Trial Agreements are in place before the research commences as well as providing line management and training for administrative trial staff (e.g. trial administrators, data entry clerks).

About You

You must hold a degree in a biomedical or associated subject, or other relevant qualification, or proven experience in clinical research. You will have experience of overseeing the conduct of multi-centre clinical trials and working to a high standard of Good Clinical Practice and according to the research governance framework. Experience and understanding of techniques for the management of medical research data are essential. Previous involvement in development of clinical reporting forms, as well as experience working with REDCap, is desirable.

The University of Oxford is committed to equality and valuing diversity. All applicants will be judged on merit, according to the selection criteria.

£39,424 to £47,779 per annum: Grade 7. This is inclusive of a pensionable Oxford University Weighting of £1,730 per year.