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Clinical Project Manager III - REMOTE

Employer
Frederick National Laboratory for Cancer Research
Location
United States
Start date
Oct 28, 2022

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time

Job Details

Clinical Project Manager III - REMOTE

Job ID: req3040
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 clinical operations leadership for domestic and international clinical trial
  • 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 implement the clinical trials, including developing overarching project plans with scope and timelines, setting expectations for operational performance of subcontractors
  • Provides oversight and technical expertise in the implementation and execution of the clinical studies
  • Reviews and/or develops operational processes, procedures, and documents required to manage projects effectively, including study planning, start up, implementation and close out
  • Anticipates obstacles and implements solutions
  • Designs and writes request for proposals, portions of abstracts, presentations, and manuscripts, participates in the development of SOPs, clinical study reports, and other clinical, regulatory, and safety documents
  • Performs initial review of site-specific informed consent documents
  • Ensures appropriate communication plans are in place to facilitate and maintain communication among scientific, regulatory, safety, monitoring, laboratory, and subcontracts project team members
  • Leads interactions with CROs and other vendors as well as with domestic and international site staff
  • Works with CMRPD financial analysts to manage budget development, cost estimating, and forecasting
  • Reviews and recommends resource changes based on identified gaps and evolving project needs
  • Monitors study accrual and assists to identify strategies to increase enrollment
  • Collates, reviews, and analyzes metrics to ensure key clinical trial project timelines are met, and identifies trends and opportunities for improvement
  • Prepares and reviews progress reports
  • Provides input and acts as part of the team that manages/monitors ancillary activities such as protocol development, manual of operations development, data management processes including Case Report Form (CRF) development, biostatistical analysis, biospecimen management, laboratory kit design, and study supply management including ordering, tracking, and labeling
  • Maintains extensive knowledge and understanding of international and domestic clinical research regulations and compliance requirements
  • Provides guidance on clinical protocol requirements and reviews and/or develops operational processes, procedures, and documents required to manage projects effectively, including study planning, start up, implementation and close out
  • Provides input for training materials for delivery to research staff and study teams on conference calls and in-person at investigator meetings
  • 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 or 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 eight (8) years of progressively responsible relevant experience in the clinical operational support of multi-center international and domestic clinical trials, including a minimum of six (6) years directly managing multiple concurrent clinical projects
  • Ability to manage large cross-functional study teams and external collaborators
  • Experience managing all facets of Phase I trials
  • Experience overseeing the work of subcontract CROs and vendors
  • Experience developing and managing project timelines utilizing software tools such as Microsoft Project
  • 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
  • Familiarity with the management of study products and supplies
  • Familiarity with Federal Acquisition Regulations (FAR)
  • Experience conducting federally funded research studies
  • Knowledge of Microsoft Project or other project tracking software
  • Ability to work diplomatically with regulatory agencies within complex international environments
  • Demonstrated success in previous positions in deployment and implementation processes

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)

#readytowork

Company

A rewarding career with global impact

Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.

Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.

We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.

Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.

Discover why joining the Frederick National Laboratory team could be the most important career step you take

 

 

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Company info
Website
Phone
301-846-1000
Location
8560 Progress Drive
Frederick
MD
21701
US

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