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Clinical Project Manager (NCI)

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Job Number:
648079
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 project and operational management of initiatives in support of the Vaccine Research Center (VRC), and to the National Institutes of Allergy and Infectious Diseases (NIAID).

KEY ROLES/RESPONSIBILITIES

  • Performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to study team members
  • Manages and coordinates project activities for the Zika Phase IIB clinical study (and others)
  • Coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting and evaluating the assigned program objectives
  • 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
  • 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
  • Assists the 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
  • Conducts site management and other meetings; develops meeting agendas and provides reports and other updates to team members and Sponsor
  • Ensures protocol compliance with monitoring in accordance with ICH GCP guidelines and regulations
  • Reviews site performance metrics and provides input on quality of work
  • Ensures site readiness in accordance with site management plan
  • Serves as a quality reviewer in routine monitoring visits with study partners
  • Ensures integrity and quality of data collected by study partners
  • Performs in-house site management, including the reconciliation of study related site issues and subject issues
  • Reviews performance metrics for monitoring and site management and provides solutions for corrective action
  • Collaborates with study team in the review of CRFs and data collection activities
  • Assists in the review and correction of discrepancies found at the site level during monitoring visits
  • Travels internationally (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 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
  • In addition to the educational requirements, 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
  • 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)
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Familiarity with Federal Acquisition Regulations (FAR)
  • Ability to speak, write, and understand Latin American Spanish and/or Brazilian Portuguese

Expected Competencies:

  • 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
  • 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


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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