Emerging Roles of Project Management in Clinical Research Organizations

Abstract

Centralized management of outsourced clinical trials is a relatively new concept in many contract research organizations (CROs). As pharmaceutical developers increasingly partner in the drug development process with CROs to manage their sponsored clinical trials, the role of project managers in CROs has undergone rapid transformation from its inception in the early 1970s. The roles and responsibilities of project managers in CROs have evolved along a path that is closely aligned to sponsor demands—to accelerate research and development time and save costs. In parallel, CROs have incorporated project management into the operational process of executing sponsored research as an instrument to achieve desired productivity and provide efficient and quality services to sponsors. This article examines the evolution of the structures/functions of project management and project managers, the development of project management and managers' roles and responsibilities, and the anticipated future direction as shaped by internal and external forces that will impact the divisional structure and functions of project managers in CROs.