Clinical Project Manager II (NCI) - Frederick, MD | Biospace
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Clinical Project Manager II (NCI)

Leidos Biomedical Research, Inc.

Frederick, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Within the Leidos Biomedical Research Inc.'s Clinical Research Directorate, 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.

The Clinical Monitoring Research Program (CMRP) provides project and operational management of initiatives in support of the Vaccine Research Center (VRC), and to the National Institutes of Allergy and Infectious Diseases (NIAID).

The Clinical Project Manager II:
Provides collaborative leadership and management oversight and coordination of research projects and other initiatives in support of the VRC
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
Participates in the execution of projects and provides technical guidance 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
Manages project risk by proactively anticipating issues and develops contingency plans and solutions
Participates in site-assessment activities 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
Interacts with auditing and monitoring agencies to facilitate the exchange of information
Maintains coordination and communication between research operations, program management, project stakeholders and team members, and acts as liaison between government customers and subcontractors on behalf of CMRP
Responsible for various subcontract planning, development and implementation activities, including preparing statements of work and evaluating proposals
Oversees and monitors the technical work of subcontractors, and performs review and verification of subcontractor deliverables and invoices
Performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to team members
Supervises multiple levels of staff
Conducts team meetings and assists in the development of meeting agendas, 16) prepares and reviews progress reports'
Travels internationally (approximately 10%)
This position is located in Frederick, Maryland


To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
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
A minimum of eight (8) years of progressively responsible, relevant experience in clinical research, including a minimum of three (3) years directly managing multiple concurrent clinical projects
Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
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
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
Ability to travel internationally
Must be able to obtain and maintain a clearance
Candidates with these desired skills will be given preferential consideration:
Familiarity with Federal Acquisition Regulations (FAR)
Ability to speak, write, and understand Latin American Spanish and/or Brazilian Portuguese a plus