Clinical Project Manager I - Infectious Disease

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale.

KEY ROLES/RESPONSIBILITIES

The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Clinical Research (DCR) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics

• Provides programmatic and management oversight and coordinates research projects including the DCR's emerging and re-emerging Viral Hemorrhagic Fever Disease outbreaks and response development, as well as other CMRP initiatives
• Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate program objectives
• Works independently with guidance and direction, as appropriate
• Participates in the execution of projects and provides programmatic and technical support in the development of administrative and operational processes, templates, procedure manuals, and other documents
• Provides support to the development and implementation of various operational plans and technical/logistical tracking systems to meet research and operational needs
• Monitors progress against plans and key deliverables
• Assists in the management of project risk by proactively anticipating issues and collaboratively developing contingency plans and solutions
• Participates in site-assessment activities, from an administrative capacity, to examine research competencies and capabilities and provides input for training and capacity building to enhance performance
• Provides assistance to clinical research teams in the development of protocol specific plans that adhere to the International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), the National Institutes of Health (NIH) Standards of Clinical Research, U.S. and international regulations
• May interact with auditing and monitoring agencies to facilitate the exchange of information
• Supports the coordination of communication between research operations, program management, project stakeholders and team members, and between government customers and subcontractors
• Responsible for various contract planning, development and implementation activities, including preparing statements of work, evaluating proposals, monitoring budgets and serving as the technical representative for subcontract management oversight for assigned activities
• Monitors the technical work of subcontractors, and performs review and verification of subcontractor deliverables and invoices
• Researches and documents impact of changes in scope of projects
• Identifies appropriate resources and organizes project teams to ensure communication and understanding of deadlines, assignments and objectives
• Prepares progress and program reports, special reports and budget documents as requested
• Performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to team members
• Coordinates team meetings and assists in the development of meeting agendas and summary reports
• Prepares and reviews internal progress reports
• Position may supervise staff
• International travel required (approximately 10%)
• This position is located in Frederick, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency
• In addition to education requirements, a minimum of six (6) years related experience in a pharmaceutical, biotechnology and/or clinical environment
• Must be detail-oriented. Possesses strong organizational skills and the ability to prioritize multiple tasks and projects
• Possesses exceptional written and oral communication skills to work closely with numerous stakeholders from diverse organizations, attend meetings as a program liaison, and keep track of meeting minutes
• Ability to work in a clinical research setting both independently and within a team
• Previous project management and/or study coordination experience including data management and research subcontracting
• Possesses extensive knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
• Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
• Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
• Ability to work diplomatically with regulatory agencies within complex international environments
• Demonstrated success in previous positions in deployment and implementation processes
• Demonstrates independent thought and leadership
• Must be willing to travel internationally
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Clinical Research or Project Management Professional with infectious disease experience
• Supervisory experience

Equal Opportunity Employer (EOE) | br>Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)