Westat is seeking an experienced Clinical Trials Project Manager to manage and coordinate project staff supporting clinical trials, participate in the development of deliverables across functional units, report to clients and oversee subcontractors, and provide timeline and budget support to the Project Director. This position based onsite in Westat’s Rockville, MD offices.
Manage, coordinate, and oversee multiple day-to-day activities and staff engaged in supporting multiple, regulated clinical trials. This includes staff working on all aspects of trials required to provide full service clinical trial support (e.g., clinical, data management, regulatory, statistical analyses).
Work closely with and support the Project Director with a variety of project administrative activities, including the development of technical support plans and budgets, project reports, client deliverables, and FDA deliverables.
Interact with the client and oversee project subcontractors and consultants.
Participate in the development of protocols and other study related materials such as informed consent forms, procedures manuals, training materials, recruitment tools, and chain of custody documentation processes.
Participate in the development and review of case report forms.
Develop site eligibility requirements and serve as a primary point of contact for recruitment of clinical trial sites.
Develop clinical and laboratory site monitoring plans in accordance with study protocols.
Develop and maintain project schedules and timelines.
Perform in-house monitoring of project data and documentation.
Work closely with and oversee Clinical Operations Managers throughout study implementation.
Work with data management staff and analysts throughout the trial.
A master's degree in science or a technical field with at least 8 years of clinical trials experience or a bachelor’s degree in science or a technical field and at least 10 years of prior clinical trial experience is required.
Previous experience working in a hospital, clinical or laboratory setting.
Candidates should possess excellent written and verbal communication skills, ability to prioritize and manage multiple, competing project tasks and develop mitigation strategies for problems and issues encountered and be organized and detail oriented.
Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits.
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the position, based on the specific position which may include, for example, identity verification, employment history, or criminal records history.
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity, or any other protected status under applicable law.
Internal Number: 14732BR
WESTAT, located in Rockville, MD is one of the foremost contract research corporations in the United States. Since 1961, we have conducted surveys and provided statistical research and related services to the agencies of the U.S. Government and to a broad range of institutional and business clients. We are an employee-owned corporation with more than 2,000 research, technical, and administrative staff and a recognized history of technical and managerial excellence.