Clinical Project Manager II (CPM II) - Ebola Response

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 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, 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 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, 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 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. The Clinical Project Manager II (CPM II) will provide operational leadership and support to various African countries.

KEY ROLES/RESPONSIBILITIES

Clinical Project Manager II (CPM II)

• 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
• Provides oversight and coordination for a number of subcontracts (supporting research in health clinics and centers in African countries)
• 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, host country investigators/colleagues, Leidos Biomed staff, subcontractors, etc.) including participating in regularly scheduled meetings/trainings
• 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
• 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
• Supervises staff
• This position will travel up to 25% internationally
• 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 educational requirements, 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 trials
• International clinical project management experience
• Clinical trial project management experience
• Progressively increasing clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience
• Experience in preparing and managing site management budgets
• Proficiency in all functions of clinical research implementation processes and conduct
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

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

Expected Competencies:

• In-depth knowledge of the clinical trials and drug development process
• Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data
• Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)
• Knowledge of clinical trial fieldwork concepts and practices
• Strong customer focus with the ability to communicate effectively, both verbally and in writing
• Strong problem solving, planning and organizational skills
• Ability to prioritize multiple tasks and projects

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