Clinical Trial Manager

Location: St Mary’s Hospital Campus, London

Job Summary

We are currently looking for a Clinical Trial Manager to join our team.

This is an exciting opportunity to join a friendly multi-disciplinary team and play an important role working on a number of large clinical trials. The post-holder will work across several international, national and local studies including, a platform trial investigating the best way to treat community acquired pneumonia and COVID-19 infection in ICU patients (REMAP-CAP) funded by the European Commission and the NIHR, a platform trial looking at using precision medicine to treat patients with ARDS (PANTHER) funded by the NIHR and the SepTiC trial looking at PCR based diagnostics, fluid therapy, GM-CSF for sepsis in Critical Care also funded by the NIHR. The post-holder will also support local critical care AI studies and other ICU trials managed by this team.

The person appointed will play a vital role managing critical care research. The post-holder will work closely with the Sponsors, and Chief Investigator in managing recruitment, regulatory submissions, site set up, data checks, and communication with sites. Site monitoring may also be required, this will include some remote site visits and on-site visits, travelling in the UK and internationally may be required.

In addition, the post holder will provide core management support to the studies and contribute to the collection of data. The successful candidate will be encouraged to take a broad interest in the field of critical care research as a whole.

Duties and responsibilities

Your key duties and responsibilities will be to support site management, data management, monitoring and administration including but not limited to:

• Be responsible for all coordination and administrative activities, including data management, to ensure the efficient running of the trials in the UK.
• Be responsible for the line management of any trial monitors and administrators.
• Establish and maintain good communication between all key stakeholders, Imperial Clinical Trials Unit (ICTU), RGIT, funder(s), the trial Sponsor (UMCU), pharmaceutical collaborators, academic collaborators, and staff at participating sites.
• Implement the principles of the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines for clinical trials and ensure that all study personnel work according to them. 
• Obtain / assist with applications for initial approvals and ensure on-going adherence to the requirements of the regulatory bodies i.e. NHS Health Research Authority, Research Ethics Committee (REC) and the Medicine Healthcare products Agency (MHRA); and submit amendments as appropriate. 

Essential requirements

Educated to degree level in a scientific discipline and with a proven interest and experience in clinical trials and medical research with experience of working in an academic or medical environment. Experience of working in critical care research is essential as is experience eCRF databases. In addition, a proven ability to take the initiative and pro-actively contribute to role responsibilities with a creative approach to problem solving.

Further Information

This role is full-time and fixed-term for 12 months in the first instance based at the St Mary’s Campus.

Should you require any further details on the role please contact: Janis Best-Lane [email protected]

For technical issues when applying online please email [email protected]

Apply online via the above ‘Apply’ button.