Clinical Project Manager – West Africa (NCI)

Frederick, Maryland
Jan 05, 2018
Required Education
Masters Degree/MBA
Position Type
Full time


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.


This effort supports the NIAID’s Emerging and Re-emerging Viral Hemorrhagic Fever Disease outbreaks and response development for natural history, vaccine, and therapeutic studies.  The Clinical Project Manager III (CPM III) will provide operational leadership and support to the Liberian-U.S. Joint Clinical Research Partnership on Ebola and collaborations with Ebola and other research initiatives in West Africa.  This position will require extended time on the ground in Monrovia, Liberia and other parts of West Africa.




  • Responsible for providing collaborative leadership and management oversight and coordination of research projects including the Division of Clinical Research’s (DCR) emerging and re-emerging Viral Hemorrhagic Fever Disease outbreaks and response development, as well as other regional CMRP initiatives
  • Provides oversight and coordination of a large number of U.S. staff who are working with Liberian and Guinean counterparts to conduct research in health clinics and centers
  • Ensures appropriate communication plans are in place to facilitate and maintain good communication channels among the many entities participating in the project (partnership leaders, National Institutes of Health (NIH) teams, Liberian investigators/colleagues, Leidos Biomed staff, subcontractors, etc.) including participating in regularly scheduled meetings/trainings
  • Works in conjunction with team leaders to manage the pharmacy center in Liberia, which is utilized to receive/store vaccines/treatments for transport to participating health clinics, and oversee the operations center, including distribution of necessary documentation, supplies and equipment to support the clinical sites, as well as logistical coordination of activities and staff at the multiple clinical sites
  • 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, provides input for training and capacity building to enhance performance, and oversees subcontractor renovations at clinical sites ensuring that projects are accomplished and supplies and equipment are procured in a timely manner
  • 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
  • Provides support to clinical research teams in the development of manuscripts/reports/abstracts to be submitted to journals/conferences
  • 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 a liaison between government customers and subcontractors on behalf of CMRP
  • Responsible for various contract 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
  • Conducts team meetings and assists in the development of meeting agendas and summary reports
  • Prepares and reviews internal progress reports
  • Facilitates integration of new technologies with existing platforms and applications and solves hardware/software interface problems
  • Serves a key role in the Partnership for Research on Ebola Virus in Liberia (PREVAIL) operations organizational structure, including support and mentorship of PREVAIL Working Group staff and participation as a member of the PREVAIL Operations and Management Team
  • Supervises staff


This position will be located in Liberia 85% or more of their time



To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:


  • Possession of a Master’s degree from an accredited college or 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 the educational requirements, a minimum of ten (10) years of progressively responsible, relevant experience in clinical research, including a minimum of six (6) years directly managing multiple concurrent clinical projects
  • Must be detail-oriented, creative and flexible
  • Strong organizational skills and the ability to prioritize multiple tasks and projects
  • Exceptional written and oral communication skills
  • Ability to work in an international 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
  • Understands data management systems and electronic data capture methods
  • Supervisory experience
  • Must be able to obtain and maintain a security clearance


Candidates with these desired skills will be given preferential consideration:

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