Project Management as a Discipline within Pharmaceutical Contract Research Organizations

Abstract

Project management is a discipline and paradigm that underpins most areas of drug development and is particularly important in the contract research organization (CRO) milieu. Data, observations, and trends developed in this paper proceed from a 2001 project management benchmarking initiative carried out by the Pharmaceutical Specific Interest Group of the Project Management Institute.

CRO project managers were asked to provide information on their academic preparation, ongoing training activities, project management experience, and pharmaceutical industry experience in order to establish a preparation and experience backdrop for understanding the benchmarking data. Similarly, project managers provided considerable detail on the CRO project management environment in an effort to better understand their companies and project management's place within their organizational structure. Areas of analysis include the longevity of the project management organization, size (full-time equivalents), and reporting structures.

Benchmarking information on the practice of project management in the CRO milieu included an examination of responsibilities, scope of work, and knowledge areas. Responsibilities, listed in order of practice frequency, include project communications, directing team meetings, coordinating and tracking project activities, leading the project team, creating and controlling project timelines, preparing agendas and minutes for meetings, managing project resources, and developing the project budget. Priority rankings on project management knowledge areas went to communication, cost, and scope. Workload responses reflect project managers' responsibility for multiple projects as the norm. Analysis of the responses and results shows important distinctions in the practice of project management in contract research organizations.