Biomedical Research Management

This subject has the following teaching availabilities in 2013:

In addition to 48 hours of coursework, students should expect to undertake a minimum of 160 hours lectures, research, reading, writing and general study to complete this subject successfully

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For the purposes of considering requests for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this subject are articulated in the Subject Description, Subject Objectives, Generic Skills and Assessment Requirements of this entry.
The University is dedicated to provide support to those with special requirements. Further details on the disability support scheme can be found at the Disability Liaison Unit website: http://www.services.unimelb.edu.au/disability/

Biomedical Research Management is aimed at people from medical and allied health professions (such as nurses, pharmacists, physiotherapists etc) and others with a science-based background and qualifications seeking the opportunity to complete specialist formal training in a specific Clinical Research discipline.

This subject provides advanced training for individuals and organisations who want to improve their performance in biomedical research project delivery. The subject covers management issues across a range of biotechnology and biomedical project types including drugs, devices and procedures development and clinical trials.

This subject will provide managers and researchers with the frameworks, tools and knowledge to enable:

• More effective management of public or privately funded research
• Better investment recommendations and decisions
• A project team and work environment that delivers successful outcomes
• Projects that deliver commercial/clinical products on time and budget
• Projects designed to manage commercial and technical risks

A 2 hour examination that assesses the learning from the course (20%), an assignment that prices a clinical research protocol and variations of a protocol according to a range of criteria (3,000 words) (30%) and a comprehensive implementation plan for a clinical research protocol that draws on the course contents in an integrated manner (5,000 words) (50%).

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This subject is not available as a breadth subject.

Students who successfully complete this course will;

• Understand and be conversant with the major activities involved in planning clinical research projects from start to finish
• Understand and be able to develop strategies to manage clinical research projects
• Understand the nuances, rationales, politics, risks and benefits of dealing with a variety of project stakeholders
• Understand the need to comply with regulatory requirements, the processes to fulfill this and be able to identify potential regulatory and legal pitfalls
• Be able to prepare and operate a budget for clinical research projects and adapt the budget for changing circumstances.
• Understand what is required to develop a business plan for the commercial development of the outcomes of clinical research
• Have the knowledge and tools for clinical research project implementation, including ongoing review, adaptation and risk management
• Be aware of a variety of leading edge developments in the biomedical research field