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The definition of complexity can vary based upon the type of project and the industry. Trade-offs on traditional projects may involve only the project manager and the client. With complex projects, the project manager needs a fluid or flexible project management methodology capable of interfacing with multiple stakeholders. Complex projects have complex scope change control approval processes. The traditional triple constraints that have been used for decades include time, cost, and scope. Demonstrating the value of project management practices in maintaining structure, oversight, and strategic alignment provides essential context for understanding how newer methodologies, such as Agile, may complement established approaches in bio/pharmaceutical projects. The chapter also draws on hypothetical case studies to reflect on the implementation of Agile methodologies in the bio/pharmaceutical project environment, which necessitates a nuanced approach that integrates both theory and practice.