This course introduces the student to the elements involved in implementing, monitoring and managing a clinical study from the perspective of the Sponsor or contract research organization. Topics include overall project planning, development of study goals, preparation of budget and contracts, implementation of monitoring visits, and effective management of research sites. Upon completion, students should be able to design and prepare a plan for the implementation and management of a sample clinical research project.
This course has been designed to introduce students to the principles and practice of Project Management as an increasingly common approach to structuring work in the pharmaceutical and biotechnology industries. The course will also emphasize skills, attitudes and values necessary to be a contributor in the workplace of both big Pharma, Canadian biotech companies and a Contract Research Organization setting.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.