Clinical Project Manager II - REMOTE

Job ID: req3039
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, tuberculosis, malaria and other infectious diseases and viruses such as hepatitis C 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 collaborative leadership and management oversight and coordination of research projects and other initiatives
• 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
• Maintains coordination and communication between research operations, program management, project stakeholders and team members, and acts as liaison between government customers and subcontractors on behalf of CMRPD
• Manages various subcontract planning, development, and implementation activities, including preparing statements of work and evaluating proposals
• Oversees and monitors the technical work of subcontractors, performs review and verification of subcontractor deliverables and invoices, and monitors scope and budget
• Collates, reviews, and analyzes metrics to ensure key clinical trial project timelines are met, and identifies trends and opportunities for improvement
• Reviews and/or develops operational processes, procedures, and documents required to manage projects effectively, including study planning, start up, implementation and close out
• Manages protocol-related document translations
• Works with CMRPD financial analysts to manage budget development, cost estimating, and forecasting
• Prepares and reviews progress reports
• Supervises, either directly or indirectly, multiple levels of staff
• Assists in the development of meeting agendas
• Position may travel 10-20% domestically and internationally

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
• A minimum of five (5) years of progressively responsible, relevant experience in clinical research, including a minimum of two (2) years directly managing multiple concurrent clinical projects
• Extensive experience in contract management and reporting
• Previous project management and/or study coordination experience including data management and research subcontracting
• Experience overseeing the work of subcontract CROs and vendors
• Excellent written and oral communication skills including strong report writing and presentation skills
• Strong interpersonal and cross-cultural communication skills
• Knowledge and understanding of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, regulatory, ethics and other requirements for domestic and international studies
• Expertise in analysis, planning, and problem solving
• Strong organizational skills with the ability to prioritize and manage multiple tasks with a high degree of accuracy and attention to detail
• Ability to work effectively both independently and as a team member with consistent ability to take initiative and make an active contribution to the team's performance
• Demonstrated proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, Project®, and Outlook®
• Ability to obtain and maintain a security clearance
  

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Clinical Research or Project Management Professional with infectious disease experience
• Experience managing all facets of Phase I trials
• Familiarity with the management of study products and supplies
• Familiarity with Federal Acquisition Regulations (FAR)
• Knowledge of Microsoft Project or other project tracking software
  

JOB HAZARDS

• Employee would receive vaccinations required and determined by Occupational Health Services (OHS) and/or mandated by Federal Health Standard Regulations as needed for international travel

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

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