Clinical research managers lead programs to develop and trial new drugs. They are responsible for completing research programs on time and within budget, while complying with ethical and regulatory requirements. Clinical research managers face new challenges from the rapid growth of scientific knowledge and the increasing complexity and pace of scientific research, according to the National Institutes of Health.
Clinical research managers require a minimum of a bachelor’s degree in a science or medical discipline, although a higher degree, such as master's in clinical research may be important for career development. Experience in leading teams of scientists and managing research projects is essential.
Project management skills are essential for this role. Clinical research managers must plan every phase of research programs, from initial concept through product development and clinical trials to submission for approval by the U.S. Food and Drug Administration. They must manage programs so that they stay on schedule and within budget. This is particularly important when a company aims to be first in the market with a new product.
Clinical research managers must be good team leaders. They determine the staffing requirements at each stage of the project and recruit qualified researchers. They set standards and guidelines for research and provide their teams with access to training and professional development programs. These managers develop methods, instruments and procedures for research and data analysis. They may mentor individual researchers and provide advice and guidance to help their teams overcome challenges and problems.
Communication skills are essential in this job. Clinical research managers must be able to communicate with a wide range of stakeholders, including research sponsors, funding agencies, regulators, product development and marketing executives and laboratory directors. In some cases, they may collaborate or share knowledge with other with other laboratories to contribute to the development of clinical research. They must have the skills to present research findings in different formats, including written reports, live presentations and conference papers.
Clinical research managers must have a good understanding of the ethical and regulatory environment governing clinical research. They must ensure compliance with the requirements of organizations such as the U.S. Food and Drug Administration and follow the recommendations of bodies such as the National Institutes of Health.
Research organizations obtain funding from drug companies, government agencies and independent grant organizations. Clinical research managers prepare proposals and present the case for the importance of their research programs. During the program, they liaise with funding partners to update them on the progress of their projects.