Clinical Project Manager I - NIAID DCR

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 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. This position will support the Collaborative Clinical Research Branch (CCRB) within the DCR.

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

• Provides operational coordination support to DCR designated high-profile clinical research projects in Indonesia, Mexico, and West Africa
• Supports the development of functionally integrated strategic and operational plans identifying critical path, resource issues, decision points and project milestones
• Assists with coordinating clinical operations management requirements with DCR and CMRPD leadership
• Provides project/program management support by performing programmatic planning, implementation, monitoring, and reporting
• Assists in the development of core project management documents such as project charters, project plans, communication plans, schedules, resource charts, reports, timelines, etc.
• Develops study-related project/program management documents incorporating input from internal and external stakeholders
• Coordinates and contributes to project/program deliverables and reports on project milestones, budget utilization, timelines, resource requirements, and risk assessments
• Provides support to the development and implementation of various technical and logistical tracking systems to meet research and operational needs.
• Assists in the identification of project risk by proactively anticipating issues and developing contingency plans and solutions
• Plans, coordinates and tracks project activities on both an individual project and program level
• Creates and maintains metrics tracking systems
• Prepares presentation materials, coordinates team meetings and assists in the development of meeting agendas and summary reports
• Works closely with project leaders and project teams to manage expectations
• Drafts, edits, and reviews statements of work, new work requests, modification requests, and vendor justifications to support the program's subcontracting activities as needed, and in collaboration with higher level clinical project managers
• Monitors the technical work of subcontractors and performs review and verification of subcontractor deliverables and invoices
• Coordinates communications between research operations, program management, project stakeholders and team members, and between government customers and subcontractors
• Participates in budget development and contract review and management
• Supervises staff
• Position will travel 30-50% domestically and internationally
• Position is located in Rockville, 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 at least three (3) years directly managing multiple concurrent clinical trial 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 detail-oriented. Possesses strong organizational skills and the ability to prioritize multiple tasks and projects
• Previous project management and/or study coordination experience including data management and research subcontracting
• Possesses 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 well under pressure, apply technical expertise and make sound decisions
• Ability to influence without authority
• Flexibility and willingness to adapt in a changing environment
• Ability to work independently and as a team member with consistent ability to take initiative and make an active contribution to the team's performance
• Demonstrated success in previous positions in deployment and implementation processes
• Demonstrates independent thought and leadership
• Proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, PowerPoint®, and Outlook®
• Must be willing and able to travel internationally
• Must be able to obtain and maintain a Public Trust Security Clearance

PREFERRED QUALIFICATIONS

• Clinical research or Project Management Professional with infectious disease experience
• Familiarity with Federal Acquisition Regulations (FARs)
• Familiarity with the management of study products and supplies, experience conducting federally-funded research studies, experience in overseeing the work of subcontractors and/or vendors, knowledge of Microsoft Project or other project tracking software
• Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners, within reasonable budgetary restrictions, and in compliance with deadlines and regulatory and client requirements
• Ability to work in a clinical setting both independently and within a team of technical specialists and project leaders
• Ability to apply working knowledge of clinical research relative to timetables to assess overall project timeliness and risks
• Supervisory experience
• Excellent communication skills (verbal and written) with the ability to develop project management staff
• Ability to judge, organize, prioritize and assign multiple tasks/projects with simultaneous orientation to detail and vision to understand the high-level interrelationships between the organization and the client

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

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