National Occupational Standard for Pre-Clinical/Clinical Trial Project Manager

Definition of Occupation

The Clinical Project Manager is responsible for managing clinical trial projects through the clinical trial lifecycle following all applicable legislation as required by the clinical trial sponsor organization, country regulations, and/or provincial requirements. The project manager is responsible for all the project management functions from the feasibility phase, selection, and approval to execution and close-out of clinical trials. Core to the success of the project is developing the project plan of execution, compiling the project team, setting the budget and schedule, and managing the achievement of project milestones against the approved project parameters.

The Clinical Project Manager also acts as the main point of communication to the project stakeholders. They ensure that informing participants, identifying problems, and solving the problems are taking place through competent specialists. They also ensure the timely delivery of all related reports, documents and records, as required, and that all related reports are delivered on time and
documents and records are managed as required.

How to use a National Occupational Standard