Clinical research project manager
Research project managers (PMs) are responsible for leading research projects to a defined business or scientific objective adequately. To promote this goal, research project managers choose the methodology and techniques for managing the research and guides the development of research instruments. They are in charge of evaluating research related fieldwork, validating collected data, authoring reports and communicating across various research constituencies.
What responsibilities does a clinical project manager job have?
CPM jobs involve planning and managing all aspects of a clinical trial. The aim of clinical trials is to evaluate the safety and effectiveness of pharmaceuticals, medical devices, or in-vitro diagnostic devices to support regulatory submissions or marketing claims. In order to manage a clinical trial adequately, CPMs manage a team of CRAs and Clinical Specialists and act as a link between the study sponsor and the clinical trial site. As a CPM, it is important to understand project management methodologies, to allow you to effectively lead a cross-functional team. The analytical and writing skills gained as a CRA are also very important because a CPM job will involve developing documents such as protocols, informed consent documents, contracts, and grants. A skilled CPM should also be familiar with the financial aspects of a clinical study, including reviewing invoices, performing daily accounting tasks, and preparing budgets. Sometimes, clinical project manager jobs may include contributing to the statistical analysis and data reporting documentation used to support a marketing clearance, approval or registration.
The national average salary for a Clinical Project Manager is $75,474 in the United States.
What is the demand for CPMs?
Demand for CPMs as high as increased global regulations is requiring more extensive clinical studies to support the safety and effectiveness claims of health-care products. CPMs may work for pharmaceutical, medical device, or in-vitro diagnostic device companies, managing the clinical studies to support the company’s product portfolio. CPMs may also work for contract research organizations (CROs)- an organization that is hired to execute clinical trials or perform other clinical research support.
What qualifications or training do I need as a CPM?
CPM come from different educational backgrounds and fields. Most have at a minimum bachelor’s degree in a sciences field such as biology, health, life sciences or bioengineering. Those with advanced degrees such as MS, MBA, Ph.D. or MD will find it easier and faster to reach the CPM level, with relevant clinical trial and project management experience. It is also necessary to have experience writing study protocols or other scientific documents. As a CPM, you will be working in a highly regulated environment and should have an expert understanding of Good Clinical Practice and other relevant regulatory requirements. You should also have exposure working with institutional review boards (IRBs) or ethics committees (ECs). Generally, a principle CRA with about 7-9 years of experience would be a strong candidate for a CPM position. A position as a clinical team lead, clinical team manager, or clinical operation leader would also serve as an excellent transition towards becoming a CPM. These positions offer valuable clinical leadership and management experience without some financial management responsibilities, such as budgeting.
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