Clinical Project Manager IV - REMOTE

Clinical Project Manager IV - REMOTE

Job ID: req2915
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

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 Microbiology and Infectious Disease (DMID) 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. 

KEY ROLES/RESPONSIBILITIES

• Provides the operational leadership, overall management, and coordination of multiple DMID high-profile, domestic, and international clinical research projects
• Supervises staff with a diverse range of expertise to include but limited to, administrative, project management, business operations, clinical research operations and trial management, biostatistics, and data management
• 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
• Develops trust and confidence with DMID staff and partners to foster highly collaborative and productive research initiatives, programs, and networks
• Supports and facilitates the coordination of communication between research operations, program management, project stakeholders and team members, and between government customers and subcontractors
• Engages with research partners to ensure expectations are clear, mutual, and appropriate, as well as identifies resources and support required by partners to achieve success
• Performs a significant level of project/program management activities including utilizing project/program management tools, techniques, and principles to organize, plan, execute, monitor, report, and evaluate program objectives including identification of critical paths, resource restrictions, and decision points
• Reviews and/or assists with the development of protocols, operational processes, procedures, and documents such as manual of operations, standard operating procedures (SOPs), quality management plans, laboratory instruction manuals, pharmacy plans, etc. for the effective management of protocols/study operations from planning through closeout.
• Oversees Leidos Biomed and subcontractor deliverables
• 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
• Facilitates the identification of project risks including those associated with timelines, scope, and budget, proactively anticipating issues, and collaboratively developing contingency plans and solutions
• Oversees contract planning, development, implementation activities, and overall management, including reviewing statements of work, identification, and selection of vendors, evaluating proposals, developing/monitoring budgets, and monitoring addressing performance concerns.  Vendor services may include clinical operations, site management, data management, biostats, safety, IRB, trial monitoring, central or specialty laboratories, etc. for all clinical study Phases
• Reviews and approves progress and program reports, special reports and budget documents as requested
• 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
• 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 and NIAID/DMID
• Interacts with CMRPD and Leidos Biomed senior leadership by participating in budget development and contract review and management for Leidos Biomed Task Orders with the government
• This position may travel up to 10% domestically and internationally
• This position maybe remote within the US

BASIC QUALIFICATIONS

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

• Possession of Master's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) Foreign degrees must be evaluated for U.S. equivalency
• In addition to 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
• 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 trial 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
• 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)
• Financial management experience as it relates to project, study, and subcontractor budgets and cost tracking
• Ability to work well under pressure
• Ability to 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
• Experience supervising a clinical trials team containing multiple management levels
• 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
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Possession of a (CHEA) Doctorate degree from an accredited college/university in a field related to clinical research/project management
• Experience managing a team of project managers
• Clinical Research or Project Management Professional with infectious disease experience
• Experience in an emerging disease/rapid response environment
• Experience with Smartsheet
• 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)

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