Project Management of any clinical trial is usually done by trained and experienced managers who are able to mange a group of sixty people or more across the country or the world.
The FDA does not require a license or certificate for project managers. Most managers must have a strong sense of coordination, organization and, most importantly, communication. Much of the manager’s time is spent emailing and getting status reports on the drug trial.
Additionally, the clinical trial manager needs to know the laws and protocol.
Bottom line: Any successful clinical trial rises and falls on the leadership of the clinial trial manager.
Drug Lifecycle Tracking Application maps the end-to-end drug approval process. It offers a one stop shop to manage Drug Lifecycle and Regulatory Review process. Call us at (240) 753-8282.