Clinical Trials Manager

Oxford Trauma and Emergency Care, Kadoorie Critical Care Research Centre, John Radcliffe Hospital, Oxford, OX3 9DU
We have an exciting opportunity for a Clinical Trials Manager to contribute to the work of the Oxford Trauma and Emergency Care group, based at the Kadoorie Centre in Oxford. The group manages research trials of complex interventions in the area of Orthopaedic Trauma in the UK as well as South Asia and Sub-Saharan Africa.
As a Clinical Trials Manager, you will work autonomously and take 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. In this post 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. You will be responsible for 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. You will oversee data entry on the computer database (assisted by a Data Entry Clerk) and perform regular systematic checks of information
held on trial database as required, and resolve contradictory or incorrect data and ensure these are followed through to a satisfactory conclusion within a reasonable timeframe.

You must hold a degree in a biomedical or associated subject, or other relevant qualification, or proven experience in clinical research. You must have experience of overseeing the conduct of clinical trials and working to a high standard of Good Clinical Practice and according to the research governance framework. You will have experience and understanding of techniques for the management of medical research data and the preparation of progress reports for internal and external stakeholders. You must demonstrate a critical and intelligent attention to detail and high standards of accuracy as well as the ability to follow and produce written procedures and set up systems to comply with such procedures. Previous involvement in the development of clinical reporting forms and working on research projects in low/middle income countries is desirable.