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project manager
WHAT IS THE ROLE OF THE PROJECT MANAGER IN A
CONTRACT RESEARCH ORGANIZATION (CRO)?
Kim M. Boericke
Senior Director, Global Project Management

inc Research

Abstract: In the clinical research setting, a project is a unique clinical trial. Within a contract research organization (CRO), a project manager is the: Project team leader, primary point of contact for the team and the client, client advocate within the CRO, manager of project change, and internal business development representative. By utilizing project management techniques, the project manager ensures that the project deliverables meet or exceed the client’s expectations. Project management is: “the application of knowledge, skills, tools, and techniques to project activities in order to meet or exceed the stakeholders’ needs and expectations from a project.” There are four critical success factors to ensure the project deliverables meet or exceed the client’s expectations. These critical factors are project team formulation, establishment of the execution plan, open communication, and proactive management.

I

n the clinical research setting, a project is a unique clinical trial. It has a discrete start date and end date. The project team works within a matrix reporting environment to ensure that the tasks required to complete the project are done within the project timeline and with quality that meets or exceeds the client’s expectations. Using project management as a management process ensures that the team works closely together to meet the project goals. Project management is “the application of knowledge, skills, tools, and techniques to project activities in order to meet or exceed the stakeholders’ needs and expectations from a project” (Project
(
Management Body of Knowledge).
Within a CRO, project management can be interpreted as “delight the client,” “support the project team,” and “delight senior management.”
This is not easy process. Most of
the

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