Project Management in Clinical Trials
The book is about both theoretical and practical aspects of Project Management in clinical trials. The audience may find explanation of different phenomena in modern clinical trials, for example, why some approaches in managing trials work and others – do not. In addition to this, the book should serve the purposes of business psychotherapy. The book is saturated with examples from real life. More
The book is based on the assumption that all principles of project management are applicable to project management in clinical trials. At the same time there is a key difference of project management in clinical trials from project management in any other area. The book explains this difference.
The book also describes targets of any project – scope, quality, timelines, and cost – in clinical trial industry. It explains why none of these can be fixed in clinical studies. It is defined on which parameters a project scope depends on in the industry.
Building blocks of project management in clinical trials described in the book are the same as in project management in any other area: planning, organizing, motivating, and controlling.
Planning is critically important for any project conduct. It is stressed in the book. Concrete principles and examples of planning are provided.
Organizing is multi-dimensional and the part of the book devoted to it is saturated with different practical tips and examples. The part telling about patient recruitment, which is vital for any clinical trial, opens it. It is outlined in the book what is needed for patient enrollment.
It is one thing to enroll patients into the study; it is another thing to keep them on study, especially if the study has many visits and lasts for a long period of time. The topic of patient retention is covered in the book.
The third component of forming per-protocol population, which is needed to analyze study data properly and to come to some definite conclusions is protocol deviation management. Protocol deviations are discouraged, but, at the same time, unavoidable in real life. The book outlines how to manage them in a best way.
During the process of data collection or once this process is completed it is important to organize the process of data cleaning properly, in a most efficient way. The book provides details of such a process organized in the right way.
The problem of Notes to Files in the industry as they relate to quality is covered here as well. Do they improve quality or make it only worse?
Study team management is touched based in the book. Is it only about achieving results or the goal for the manager is more complex? What does it include apart from pure result-orientedness? The right answers to these questions can save a lot of teams.
Any managing of others begins with self-organization, so the book has a small section devoted to it.
Motivating is described in the book. The simplest (still effective) thing a manager can do is to thank their team members whenever it is deserved. But there may be even more important technique, if it may be called “a technique” at all, developed and implemented by the author, which is shared in the book.
Controlling is a vital part of management. The book describes how to implement it properly from the practical standpoint.
The three connecting processes within project management are described: communication, decision making, and leadership. The chapter includes practical tips that would be useful for project managers working within clinical trials.
Is it the right thing to promote Project Managers from within your organization or to hire them? Both approaches are right and both have their own advantages and disadvantages, which are covered in the book.
The book also touches base on risk and vendor management, emotional burning out, and different styles of management.
The primary audience of the book is Project Managers located in all regions of the world working in clinical trial industry. The highest number of these specialist is located in the US, Western and Eastern Europe. The secondary audience include other clinical trial professionals: Clinical Research Associates, Project Assistants, Clinical Team Managers, top management of Contract Research Organizations, investigators, and so on. The book may also be interesting for Project Managers working in areas other than clinical trials.
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