Trial Managers

The Trial Managers (TM) provide the day-to-day trial management throughout the life cycle of the trial, in line with sponsor, regulatory and research governance requirements. The TM undertakes trial set up including all regulatory approvals (MHRA), HRA submissions and their related reports, as well as any necessary subsequent amendments, site initiation and day to day management of trial conduct, performing off and on-site monitoring, and ensuring the trial is conducted to Good Clinical Practice requirements, as well as supporting study site personnel to achieve their milestones.  

The TMs work closely with the Data Manager, Senior Trial Manager and Clinical Trial Administrator contributing to the development of the trial protocol, database, training and ongoing coordination of trial sites and monitoring activities. 

The TMs undertake safety management and reporting through the oversight of Adverse Events, Adverse Reactions, and Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), Serious Adverse Device Effects (SADEs) and Severe Unexpected Serious Adverse Reactions (SUSARs). 

The TMs coordinate the Trial Steering Committee, Independent Data Monitoring Committee and chairs the Trial Management Group (TMG) and associated trial meetings.