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Clinical Project Manager I - COVID-19

Job ID: req1105
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases. 

Position Overview:

PROGRAM DESCRIPTION
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. 

The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID).  CMRPD is responsible for establishing and maintaining an Operations Center (OC) to support an initial clinical trial for COVID-19 with a primary base of operations co-located with various divisions of NIAID at 5601 Fishers Lane, Rockville, MD.  In addition, CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging infectious disease studies.  All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).  This position will support the Operations Center and various divisions of NIAID. 

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

  • Provides programmatic and management oversight and coordinates research projects
  • 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
  • Position will travel 10-20% domestically and internationally
  • 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
  • A minimum of six (6) years of progressively responsible and responsive experience, achievement and organizational visibility in project management, including directly managing multiple concurrent clinical trial projects related experience in a pharmaceutical, biotechnology and/or clinical environment
  • Must be detail-oriented
  • 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 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
  • Demonstrated success in previous positions in deployment and implementation processes
  • Demonstrated independent thought and leadership
  • Ability to travel up to 20% domestically and internationally
  • Must be able to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

  • A Clinical Research or Project Management Professional with infectious disease experience is preferred
  • Familiarity with Federal Acquisition Regulations (FARs)

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