Project Manager

• Conduct trainings relevant to the role and keep training records up to date;
• Assist with administrative aspects of clinical trials, providing support to the study team (monitors and clinical project managers);
• Assist in collecting and preparing documents from research sites during the conduct of the clinical trial;
• Prepare the study Trial Master File (TMF) and assist in its ongoing maintenance;
• Prepare the Investigator Site File (ISF);
• Conduct clinical trial activities in accordance with applicable regulations, Good Clinical Practice (GCP), and protocol guidelines;
• Support meeting activities such as scheduling, planning, and preparing minutes;
• Provide support to clinical research monitors, clinical project managers, the monitoring manager, and the head of operations;
• Assist in identifying potential research sites;
• Perform co-monitoring activities for training purposes and assist clinical research monitors during site monitoring visits;
• Support the clinical research monitor in the absence of the clinical project manager.

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