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., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH.
CMRPD’s ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers.
CMRPD’s support services are aligned with the program’s mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects.
CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually.
These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases.
CMRPD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD’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
Responsibilities include but are not limited to:
- 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 data management and statistical analysis subcontractors, performs review and verification of subcontractor deliverables and invoices, and monitors scope and budget for a program supporting up to twenty (20) Phase 1 and Phase 2 trials.
- Reviews data management reports/queries generated by the subcontractor, as needed
- Helps identify and troubleshoot potential problems with subcontractor’s clinical trial data
- Liaison between government, Leidos Biomed, and subcontractor personnel to ensure resolution of data management issues at the subcontractor level
- Manage and oversee timelines for delivery of functional data management systems, statistical analysis plans, database lock, data set transfer, and clinical study reports by the subcontractor
- 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
- Works with CMRPD financial analysts to manage budget development, cost estimating, and forecasting
- Prepares and reviews progress reports
- Assists in the development of meeting agendas and leading subcontract meetings.
- May supervise staff
- This position is 100% Telework during US East Coast hours
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 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
- 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 and phase II 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
- Strong clinical data management capabilities
- Experience with database development/programming
- Excellent communication skills
- Experience with supervision of data management and data entry staff
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
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