Project Management
Under the direction of the Project Manager, Concentrics will manage all aspects of your clinical trial—this includes site management and overall project management. The Project Team consists of representatives from each of the technical areas involved in the project with the Project Manager as the primary contact for the duration of the project.
Concentrics will communicate with the sponsor on a regular basis to keep team members updated on all project activities. The ultimate responsibility for the successful, timely completion of all aspects of the project will lie with the Project Manager. Project Manager responsibilities include:
- providing a central point of contact (CPOC) for all study activities for the sponsor;
- oversight of site management and maintenance including selection, contracting, training, tracking, communicating;
- working with the sponsor to prepare for the Investigator Meeting and study start-up;
- tracking timelines and ensuring that study milestones are met;
- assuring timely questionnaire or CRF review, cleaning and query resolution to allow for continuous data cleaning;
- managing the overall study budget, as well as the advertising, Institutional Review Board (IRB) and site budgets;
- overseeing internal and sponsor project team meetings;
- maintaining working project file (maintaining the Trial Master File (TMF);
- ensuring effective communication between sites, monitors, data management, statisticians, medical writers, consultants and the sponsor;
- proactively identifying and resolving critical issues;
- reporting study progress to the sponsor on a pre-determined basis; and
- ensuring that all project documentation is consistent and correct.
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