Frederick National Laboratory for Cancer Research

Clinical Project Manager II

Location
Frederick, MD, USA
Posted
Aug 28, 2020
Ref
req1268
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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) / Clinical Consulting and Support-Office of the Director (CCS-OD) provides clinical trial management support to the National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR).

KEY ROLES/RESPONSIBILITIES
  • Supports the CPM IV in collaboration with the CMRPD Director as well as assigned NIAID Program Officers to ensure the success of the various initiatives and efforts (e.g., Rapid Response Toolkit, SharePoint intranet, Biostatistical support, DCR Special Projects, etc.)
  • Performs project and programmatic planning, research, contracting, analysis, correspondence control, communication and liaison activities
  • Manages CROs and other vendors to ensure quality service
  • Evaluates and participates in the selection of consultants, CROs and other vendors to facilitate the conduct of clinical research
  • Creates and implements complex project schedules, budgets and objectives for multiple clinical projects of high complexity
  • Determines need for and impact of changes in scope of project and makes and implements recommendations based on determinations
  • Gains concurrence, approval and consensus from stakeholders regarding the various project aspects and adjusts accordingly
  • Identifies appropriate resources and organizes project teams to ensure communication and understanding of deadlines, assignments and objectives
  • Oversees the ongoing review of CMRPD and DRC project status and identifies risks
  • Develops, recommends and implements risk mitigation solutions and implements as appropriate
  • Serves as the technical representative for the comprehensive solicitation, review and award of contract activities
  • Serves on a project management team to provide expert guidance for strategic planning and project tracking implementation
  • Prepares progress and program reports, special reports, and prepares and coordinates planning and budget documents
  • Provides overall budget management including monthly review
  • Coordinates programmatic responses and preparation of cost estimates
  • Creates and reviews high-level CMRPD documents and reports
  • Provides oversight and participates in meetings, retreats and site-visits among various groups
  • Performs a variety of high-level administrative functions including the planning and implementation of overall program strategies and the overall coordination of administrative program level functions
  • Interfaces with both scientific and administrative government officials and hires and supervises staff
  • Work is performed independently
  • This position is located in Frederick, Maryland

BASIC QUALIFICATIONS
  • Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation in a related scientific or clinical field (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of eight (8) years of progressively responsible and responsive experience, achievement and organizational visibility in project management, including a minimum of three (3) 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 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
  • Project Management Professional (PMP) certification
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Familiarity with regulatory processes/strategies, operational and/or product quality management and clinical trials management


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

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