Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.
Westat is seeking a Clinical Task Manager to support a variety of activities related to implementation and monitoring of trials performed by participating clinical sites and ensure the quality of the trials performed.
Collaborate with the Project Manager to ensure monitoring plans for trials performed are in alignment with project goals.
Develop and maintain risk-based Clinical Monitoring Plans and Safety Plans for trials, and create and implement study-specific clinical monitoring tools and documents.
Arrange and oversee site qualification visits and subsequent monitoring visits.
Gather and examine trial documentation and coordinate site management activities.
Serve as the main point-of-contact for site staff, and participate in meetings with site investigators and their research staff to discuss study progress.
Coordinate and supervise Clinical Research Associates assigned to perform clinical monitoring, provide them with project-specific training, and meet with them regularly.
Manage timelines, budgets, and submitted expenses of the clinical site monitors and any managing and supervising any subcontractor or consultant involved with pharmacovigilance.
Perform remote clinical monitoring activities as outlined in the Clinical Monitoring Plans to assess ongoing quality of the trials at each site.
Collaborate with the Project Manager to review, finalize and maintain clinical trial protocols, informed consent forms, manuals of procedures, and other study materials.
Assure compliance with SOPs and local regulations, and CFR, ICH and GCP guidelines.
Collaborate with protocol chairs to write technical reports such as annual reports, safety reports and final clinical study reports.
A Bachelor’s in nursing or life sciences is required.
At least 8 years of work experience related to conducting or supporting clinical trials.
Experience overseeing staff.
Be available for a limited amount of travel (≤ 10% annually).
Experience working in surgical clinical settings.
Proficient with Microsoft Office Word and Excel.
Candidates must have outstanding verbal and written communication skills. You should be a critical thinker who is team-oriented and can effectively work independently and prioritize tasks.
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: 14771BR
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.