ABSTRACT

Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions.

Features

    • Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development.

    • Provides the most up-to-date and best practices, techniques, and methodologies in project management.

    • Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process.

    • Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics.

    • Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.

    part 1|87 pages

    The Role of PM in Drug Development

    part 2|123 pages

    Contemporary Topics in Drug Development

    part 3|58 pages

    Gridall: A Comprehensive Framework for Managing Projects

    chapter 14|6 pages

    Introduction to GRIDALL

    chapter 15|12 pages

    Goals

    chapter 16|9 pages

    Risks

    chapter 17|6 pages

    Issues

    chapter 18|10 pages

    Decisions

    chapter 19|5 pages

    Actions

    chapter 20|6 pages

    Lessons Learned