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Clinical Project Manager (NCI)

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Job Number:
652077
Job Category:
Healthcare / Life Sciences / Medical
Location:
FREDERICK, MD US
Schedule:
Full-time
Travel:
Yes, 10% of the time
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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, CMRP’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. CMRP’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, CMRP 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.  CMRP’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 (CMRP) provides support to the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) portfolio of infectious disease vaccine-candidate clinical trials by providing the required services and oversight to support clinical trials.

KEY ROLES/RESPONSIBILITIES

The Clinical Project Manager I:

  • Provides support for the implementation of clinical studies
  • Leads the technical aspects of procurement efforts
  • Works with Leidos Biomed’s Subcontracts department and other stakeholders to prepare subcontractor statements of work, evaluate proposals, monitor budgets, invoices, and deliverables
  • Serves as the technical representative for subcontract management oversight for assigned activities
  • Participates in the execution of projects and provides programmatic and technical support 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
  • Assists in the management of project risk by proactively anticipating issues and collaboratively developing 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
  • May interact with auditing and monitoring agencies to facilitate the exchange of information
  • Supports the coordination of communication between research operations, program management, project stakeholders and team members, and between government customers and subcontractors
  • Identifies appropriate resources and organizes project teams to ensure communication and understanding of deadlines, assignments and objectives
  • Prepares 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 assists in the development of meeting agendas and summary reports
  • Prepares and reviews internal progress reports
  • May supervise staff
  • Travels internationally as needed (approximately 10%)
  • This position is located in Frederick, Maryland


Qualifications:

BASIC QUALIFICATIONS

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

  • Possession of a Bachelor's 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 six (6) years related experience in a pharmaceutical, biotechnology and/or clinical environment
  • Exceptional written and oral communication skills to work closely with numerous stakeholders from diverse organizations, attend meetings as a program liaison, and disseminate meeting information to relevant stakeholders
  • Ability to work in a clinical research setting both independently and within a team
  • Previous project management, clinical study coordination, clinical data management, or research subcontracting experience
  • Knowledge of 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 diplomatically with regulatory agencies within complex international environments
  • Ability to travel internationally as needed, approximately 10%
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Infectious disease and contracts experience
  • Certified Clinical Research Professional (CCRP)
  • Certified Project Management Professional (PMP)
  • Familiarity with Federal Acquisition Regulation (FAR)

Expected Competencies:

  • Must be detail-oriented
  • Strong organizational skills and the ability to prioritize multiple tasks and projects


Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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