CRU-GLOBAL appoints a clinical project manager to be the team leader for each clinical study. The clinical project manager leads the team of professionals that may include CRAs (clinical research associates), data managers, biostatisticians, medical writers and regulatory associates. Teams can be made up of staff members, contractors and/or consultants from either CRU-GLOBAL or the study sponsor. The clinical project manager also promotes interaction, clarifies team member responsibilities and ensures accountability by individual team members as well as by the project team as a whole.
Our clinical project manager is responsible for developing the project management plan, clinical monitoring and communications plan and study timelines. Our clinical project manager also oversees the development of the trial master file for each study and is responsible for ensuring that all of the team members, including those representing the sponsor, are kept abreast of study progress.