Leidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.
The breadth of FNLCR’s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes. LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.
The Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP’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. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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. CMRP’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.
This effort supports the NIAID DCR’s Emerging and Re-emerging Viral Hemorrhagic Fever Disease outbreaks and response development for natural history, vaccine, and therapeutic studies.
The Clinical Project Manager II: 1) provides overarching support for operations and the Natural History Study, 2) provides operational and technical expertise and oversight for multiple aspects of the study planning, management, and execution in support to the Ebola Response Program as well as contract management activities in coordination with the Leidos Biomed CMRP Program Director and Research Contracts Department, 3) utilizes project/program management tools and techniques to organize, plan, execute, report and evaluate program objectives, 4) participates in the execution of projects, 5) provides technical support in the development of administrative and operational processes, templates, procedure manuals, and other documents, 6) provides support to the development and implementation of technical/logistical tracking systems to meet research and operational needs, 7) monitors progress against plans and key deliverables, 8) assists in the management of project risk by proactively anticipating issues and collaboratively developing contingency plans and solutions, 9) participates in site-assessment activities from an administrative capacity to examine research competencies and capabilities, 10) provides input for training and capacity-building to enhance performance, 11) 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, 12) interacts with auditing and monitoring agencies to facilitate the exchange of information, 13) supports the coordination of communication between research operations, program management, project stakeholders, team members, government customers and subcontractors, 14) develops contract planning and implementation activities, including preparing statements of work, evaluating proposals, monitoring budgets and serves as the technical representative for subcontract management oversight for assigned activities, 15) monitors the technical work of subcontractors, performs review and verification of subcontractor deliverables and invoices, 16) researches and documents impact of changes in scope of projects, 17) identifies appropriate resources and organizes project teams to ensure communication and understanding of deadlines, assignments and objectives, 18) prepares progress and program reports, special reports and budget documents as requested, 19) performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to team members, 20) coordinates team meetings and assists in the development of meeting agendas and summary reports, 21) prepares and reviews internal progress reports, 22) supervises staff as needed, and 23) travels internationally, approximately 30-50%, to West Africa.
Possession of a Bachelor's degree in biomedical science from an accredited college or university or four (4) years related experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
In addition to education requirements, a minimum of eight (8) years related experience in a pharmaceutical, biotechnology and/or clinical environment including three (3) years directly managing multiple concurrent clinical projects
Exceptional written and oral communication skills
Ability 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
Extensive knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
Knowledge of clinical trial fieldwork concepts and practices with a specific focus on 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
Experience in deployment and implementation processes
Ability to travel internationally
Clinical Research or Project Management Professional (PMP)
Infectious disease experience
Familiarity with Federal Acquisition Regulations (FARs)
Leidos is an applied solutions company focused on markets that are seeing converging business and technological trends, and address basic, enduring human needs: defense and national security, health and life sciences, and energy, engineering and infrastructure. The Company's approximately 20,000 employees serve customers in the U.S. Department of Defense, the intelligence community, the U.S. Department of Homeland Security, other U.S. Government civil agencies and commercial health and engineering markets. Leidos is an Equal Opportunity Employer.
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Clinical Project Manager II job in Frederick, MD