The Clinical Trials Project Manager (CPM) works closely with a study’s Principal Investigator to form the Study Management Team (SMT) for each protocol. You will be responsible for the overall planning, execution, and management of studies as well as participate in organizational process improvement initiatives.
- Work with the Principal Investigator and collaborators to develop protocols and all documents required to initiate and conduct clinical studies, including informed consent forms, investigator brochures, case report forms, study procedure manuals, etc.;
- Select and manage external service providers;
- Ensure that clinical study timelines are consistent with company’s goals;
- Help select study investigators/sites and evaluate adequacy to perform research and meet study timelines;
- Manage studies to meet enrollment goals;
- Generate and maintain study timelines. Identify and timely communicate trial issues that will impact budget, resources and/or timelines;
- May participate in oversight monitoring activities, as needed;
- Previous on-site monitoring experience is required;
- Contribute to wider organizational goals and/or activities as assigned;
- Work with the Principal Investigators to ensure the study remains within forecasted budget and escalate as needed.
- Travel up to 25% may be required