Common Questions For a Clinical Research Project Manager
Research project managers (PMs) are responsible for leading research projects to a defined business or scientific objective. To reach this goal, research project managers utilize different methodologies and techniques for managing and guiding the development of research instruments. They are also 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. They also act as a link between the study sponsor and the clinical trial site. As a CPM, it is important to understand project management methodologies, like those taught in the Advanced Clinical Research Project Manager Certification. They will allow you to effectively lead a cross-functional team.
Analytical and writing skills 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 research manager jobs may include contributing to the statistical analysis and data reporting documentation used to support a marketing clearance, approval or registration.
How much do CPMs earn?
The average clinical research manager salary is $75,474 in the United States.
What is the demand for CPMs?
Demand for CPMs increases, as there are increased global regulations 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. CPMs may also work for contract research organizations (CROs)- an organization that is hired to outsource clinical trials or perform other clinical research support.
What qualifications or training do I need as a CPM?
CPM can come from different educational backgrounds and fields. Most have, at a minimum, a 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 position, as long as they have relevant clinical trial and project management experience.
As a CPM, you will be working in a highly regulated environment and should have an expert understanding of Good Clinical Practice (ICH-GCP) 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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