The Clinical Trial Manager (CTM) will support the Associate Director, Clinical Site Manager (CRA) and clinical sites in the delivery of all site level clinical trial activities for assigned clinical studies. The CTM will conduct monitoring or co-monitoring visits as required. Working closely with the Clinical Operations team the CTM will maintain an overview of clinical site status and the progress of assigned studies to ensure all site level activities are delivered to time and quality.
Assist the Associate Director with oversight of site management and monitoring activities/staff including the tracking and review of monitoring trip reports and escalate any trends with respect to data quality or study conduct
Track and report on the progress of assigned clinical studies including site activation, patient enrolment and monitoring visits
Ensure that monitoring visits are performed in accordance with the protocol, monitoring plan and applicable Autolus SOPs
Contact sites as needed for data entry/data quality concerns and alert CRA of any issues prior to the next scheduled monitoring visit
Assist in the investigator selection and qualification process
Assist with study start up activities
Conduct monitoring and/or co-monitoring visits at study site as required