Clinical Project Manager II, Project Management

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, tuberculosis, malaria and other infectious diseases and viruses such as hepatitis C 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) Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging infectious disease studies globally. All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

• Provides collaborative leadership and management oversight and coordination of research projects and other initiatives
• 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 minimal direction and often provides direction to others
• 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
• 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 CMRPD
• Is responsible for various subcontract planning, development and implementation activities, including preparing statements of work, evaluating proposals including pricing, monitoring budgets, and serving as the technical representative for subcontract management oversight for assigned activities
• Develops payment models for clinical trials sites
• Provides input into Leidos Biomed reporting deliverables
• 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
• Prepares and reviews progress reports
• Position may travel 10-20% domestically and 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
• 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
• Extensive experience in contract management and reporting
• Previous project management and/or study coordination experience including data management and research subcontracting
• Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
• Must be able to obtain and maintain a clearance

PREFERRED QUALIFICATIONS

• Clinical Research or Project Management Professional with infectious disease experience
• 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
• Familiarity with the management of study products and supplies
• Familiarity with Federal Acquisition Regulations (FAR) and experience conducting federally funded research studies
• Experience in overseeing the work of subcontractors and/or vendors
• 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
• 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

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

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