Pharmaceutical companies develop and sell drugs to improve health or cure disease. All drugs are required to go through documented clinical trials, and approved by the U.S. Food and Drug Administration (FDA) before they are sold to the general public.
A pharmaceutical clinical project manager oversees one or more clinical development efforts or clinical trials.
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Education, Skills and Experience
Minimal requirements for a pharmaceutical clinical project manager include a bachelor's degree and several years of experience in other clinical research occupations, along with management experience. Strong knowledge of clinical operations and the regulatory process is also required.
In some cases, specialised medical knowledge might be required, depending upon the projects the manager will be overseeing.
Pharmaceutical clinical project managers oversee and coordinate development and trial projects. Responsibilities typically include developing budgets, time lines, and quality guidelines for projects, thereby ensuring that expectations are met. The project manager guides the selection and management of clinical research organisations used for the project study trials, and they coordinate the delivery of clinical trial supplies, as well.
Another expectation is that the pharmaceutical clinical project manager pro-actively works with members of the project team, identifying issues that might delay the project and making recommendations to improve time lines for project completion. They also compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data.
Management responsibilities include facilitating meetings and supervising the clinical project team. Pharmaceutical clinical project managers offer direction and make critical decisions related to assigned projects. They work with other members of the pharmaceutical organisation, reporting project progress and making recommendations to align with therapeutic and organizational strategies.
Most organisations will assign one specific area of clinical research for each clinical project manager. Those phases generally include drug discovery through the start of trials, phase one, two or three of clinical trials through FDA approval, and phase four of clinical trials, which encompasses ongoing research and development after the drug is approved and sold. This can include discovering other benefits of the drugs and reporting discoveries to the pharmaceutical organisation.
Average salary for a pharmaceutical clinical manager can range from £51,350 to £82,550 a year, depending on the level of clinical knowledge and experience required for a particular project, as well as job location. While these are average salaries, a pharmaceutical clinical project manager with a Ph.D. and strong project management experience can earn a much higher salary. Still, there are far more positions available in clinical research and project management for those with bachelor's or master's degrees.
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