Clinical Project Manager I

Job ID: req3332
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 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

WithinLeidos Biomedical Research Inc., operator of the Frederick National Laboratoryfor Cancer Research, the Clinical Monitoring Research Program Directorate(CMRPD) provides high-quality comprehensive and strategic operational supportto high-profile domestic and international clinical research initiatives sponsoredby the National Cancer Institute (NCI), the National Institute of Allergy andInfectious Diseases (NIAID), the National Institutes of Health (NIH), andseveral other institutes within NIH. CMRPD’s ability to provide rapid responses and high-quality solutions, andto recruit and retain experts with a variety of backgrounds, allows thedirectorate to facilitate strategic support to the growing clinical researchportfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD’ssupport services are aligned with the program’s mission to provide comprehensive clinical trialsoperations and program/project management services to advance scientific clinicalresearch that complies with applicable regulations and guidelines, maintainsdata integrity, and protects human subjects. CMRPD services include clinical trialsmonitoring, regulatory affairs support, clinical safety oversight, protocolnavigation/protocol development, and programmatic and project managementsupport to facilitate the conduct of more than 400 Phase I, II, and IIIdomestic and international trials annually. These trials investigate theprevention, diagnosis and treatment of cancer, influenza, HIV, infectiousdiseases and emerging health challenges like Ebola virus and COVID-19, heart,lung, and blood disorders, parasitic infections, and rare and neglecteddiseases. CMRPD’s collaborative approach to clinical research support and theexpertise and dedication of staff to the continuation and success of CMRPD’s mission has contributed to improving theoverall standards of public health on a global scale.
TheClinical Monitoring Research Program Directorate (CMRPD) providesproject and operational management of initiatives in support of the NationalInstitutes of Allergy and Infectious Diseases (NIAID), Division of ClinicalResearch. This effort supports emergingand re-emerging Viral Hemorrhagic Fever (VHF) Disease outbreaks and responsedevelopment for natural history, vaccine, and therapeutic studies.

KEY ROLES/RESPONSIBILITIES

• Coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting, and evaluating the assigned program objectives
• Responsible for various subcontract planning, development and implementation activities including preparing statements of work (SOW), evaluating proposals, and serving as the technical representative for subcontract management oversight including subcontract modifications
• Oversees and monitors the technical work of subcontractors and performs review and verification of subcontractor deliverables, budgets, and invoices
• Provides administrative, management, and/or programmatic support, including planning, research, analysis, and correspondence control/communication within the CMRPD, and serves as the main contact for senior managers and various levels of government officials or research collaborators
• Supports highly complex international projects and provides technical coordination for the development and administration of domestic and international research subcontracts during all life cycle stages, from concept development through award and closeout
• Coordinates the development of project management and communication plans for all outsourced requirements and monitors all aspects of project execution
• Assists with administration and ensures major components and initiatives are well integrated to move forward efficiently and effectively in the areas of clinical research, subcontracts/consulting agreements, training, and resource management
• Acts as a liaison among various internal and external groups, teams, and Leidos Biomedical Departments to facilitate domestic and international clinical trials research
• Provides meeting support as necessary to help facilitate communication between government officials, partners, subcontractors, and other CMRPD staff
• Stores, organizes, and maintains study documents in various platforms
• Develops project timelines, tracks progress, monitors and prepares budget operating reports
• Provides management oversight to the program operations/logistics that include purchasing and shipping of clinical research or laboratory equipment/supplies, office supplies and service maintenance agreements
• Responsible for implementing research initiatives and operating guidelines utilizing standard policies and procedures
• Assists in monitoring and reporting of program budgets and develops project timelines for tracking progress
• May supervise administrative or program management support staff
• Position may travel 10-20% domestically and internationally
• Position is located in Frederick, Maryland with the option for telework

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a (CHEA) Bachelor's degree from an accredited college or university in a field related to biomedical research, clinical trials, health, business, or four (4) years related experience in lieu of degree
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirements, a minimum of five (5) years of progressively responsible experience in clinical research and/or administration of grants and contracts
• Previous project management and/or research management experience including research subcontracting
• 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 have the ability to manage, organize, and communicate effectively, orally and in writing, with program leaders
• Possesses strong interpersonal, leadership, and analytic skills
• Demonstrates good judgment and decision making, attention to detail, personal accountability, administrative abilities, and the ability to handle multiple tasks and priorities effectively
• Possesses strong organizational and project coordination skills and enthusiasm for grants, contracts, and data management
• Ability to provide oversight for detail-oriented tasks and projects
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Health science, clinical trials, or laboratory experience, particularly in infectious diseases
• Federal contracts/research subcontracts administration/management
• Budget development and oversight
• Report writing and metrics tracking
  experience
• Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
• Knowledge of clinical research fieldwork concepts and practices
• Familiarity with the management of study products and supplies
• Familiarity of Federal Acquisition Regulations (FARs) and Federal Travel Regulations (FTRs)
• Demonstrates proficiency in Windows and Microsoft Office Suite, including Word, Excel, and Outlook
• Demonstrates proficiency in video conferencing tools and hosting remote web-based meetings using platforms such as Zoom or MS Teams
• Bilingual abilities English/French is a plus

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