Clinical Project Manager IV

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

• Provides the operational leadership, overall management and coordination of DCR designated high-profile clinical Special Projects in Indonesia, Mexico, and West Africa
• Works closely with program and project leadership to develop overarching project plans, sets expectations for operational performance and provides oversight and technical expertise in the implementation and execution of project/program strategy
• Provides a high level operational and logistical support to multiple domestic and international clinical trials and special projects
• Develops trust and confidence with CCRB staff and partners to foster highly collaborative and productive research initiatives, programs, and networks
• Engages with research partners to assure expectations are clear, mutual and appropriate, as well as identifies resources and support required by partners to achieve success
• Contributes to organizational development activities including strategy management and operational planning related to routine review and evaluation of goals and performance metrics to ensure mission alignment with overall strategic plans within CMRPD, NIAID and CCRB
• Performs a significant level of project/program management activities including utilizing project/program management tools, techniques, and principles to organize, plan, execute, report, and evaluate program objectives including identification of critical paths, resource restrictions, and decision points
• Provides support to the development and implementation of various technical and logistical tracking systems to meet research and operational needs
• Monitors progress against plans and key deliverables
• Facilitates the identification of project risks, proactively anticipating issues and collaboratively developing contingency plans and solutions
• Supports and facilitates the coordination of communication between research operations, program management, project stakeholders and team members, and between government customers and subcontractors
• Researches and documents the impact of changes in scope of projects
• Identifies appropriate resources, organizes project teams, and directs the work of other project managers to ensure staff continuity so deadlines, assignments and objectives are met.
• Prepares and reviews 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 assisting in the development of meeting agendas and summary reports
• Carries out various contract planning, development and implementation activities, including preparing statements of work, evaluating proposals, developing/monitoring budgets and serving as the technical representative for subcontracts.
• Monitors the technical work of subcontractors and performing review and verification of subcontractor deliverables and invoices
• Participates in budget development and contract review and management
• Maintains extensive knowledge and understanding of international and domestic clinical research regulations and compliance requirements
• Provides guidance 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
• Reviews and/or develops operational processes, procedures and documents such as manual of operations, standard operating procedures (SPOs), data management processes including Case Report Form (CRF), laboratory kit design, study supply management including ordering, tracking and labeling as well as manage all aspects of the procurement, distribution, and retesting of investigational study product
• Provides guidance on clinical protocol requirements, site selection activities and reviews and/or develops operational processes, procedures, and documents required to effectively manage protocols, including study planning, start up, implementation and close out
• Participates in study data review and other review activities as assigned
• Participates in site-assessment activities to examine research competencies and capabilities and providing input for training and capacity building to meet protocol requirements and enhance performance
• Oversees the development of training materials for delivery to research staff and study teams on conference calls and in-person
• Oversees deliverables, including evaluation of protocol reviews and monitoring requirements, site initiation visits, review and approval of monitoring plan, ensure monitoring is conducted in accordance with SOPs and monitoring plan, ensure timeliness of monitoring and follow-up action items are completed, travel planning, metrics, and requested training presentations
• Oversees clinical trial sites' adherence to protocol and regulatory requirements by review of monitoring reports, certified quality auditor -good clinical practices (CQA-GCP) audit reports, communication with investigators, study site personnel, DCR Clinical Monitoring Team, Clinical Research Associates (CRA), and other Contract Research Organizations (CRO) staff
• May interact with auditing and monitoring agencies to facilitate the exchange of information
• Supervises staff
• This position will travel 30-50% domestically and internationally
• This position is located in Rockville, Maryland

BASIC QUALIFICATIONS

• Possession of a Doctorate degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (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 and responsive experience, achievement and organizational visibility in project management, including at least eight (8) years directly managing multiple concurrent clinical trial projects
• At least three (3) years of experience managing a team of project managers
• 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
• 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
• Detail oriented with 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
• 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 and influence without authority
• Ability to apply technical expertise and make sound decisions
• 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
• Supervisory experience
• Proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, PowerPoint®, and Outlook®
• Ability to travel domestically and internationally up to 50%
• 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)
• 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

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