Program Manager II in Frederick, MD

Description

Program Manager II

Job ID: req1598
Employee Type: exempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.  

 Position Overview:

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), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) Clinical Center (CC), 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 directorate staff to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other divisions/offices/centers within the NIH.  CMRPD's support services are strategically aligned with the program's mission to provide comprehensive clinical trials operations program/project management services to advance scientific clinical research and to assist NIH researchers in providing the highest quality of clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include comprehensive clinical trials management, regulatory, pharmacovigilance, protocol navigation/protocol development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials. These trials investigate the prevention, diagnosis, and treatment of cancer, HIV/AIDS, influenza, and other infectious diseases and emerging health challenges like Ebola virus and COVID-19. 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 specialized support for initiatives and special projects sponsored by the National Institute of Allergy and Infectious Diseases Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and other emerging and re-emerging infectious diseases. 

KEY ROLES/RESPONSIBILITIES

• Provides programmatic support to the NIAID Division of Clinical Research (DCR) research portfolio and CMRPD's research response efforts
• Serves as a liaison for stakeholder communications in support of high-profile projects
• Interfaces with government officials, research partners, administrative officers, program specialists, panel members, and CMRPD staff members
• Reviews and edits public facing guidelines and communications
• Coordinates logistical needs for virtual and in-person meetings, drafts agendas when necessary, assists with scheduling meetings and distributing meeting materials
• Documents and tracks action items for panel leaders, organizes task timelines and due dates
• Assists with version control of document revisions
• Categorizes and organizes relevant project documents
• Facilitates cloud content management and file sharing services
• Analyzes, summarizes, and tracks survey responses and other project-related data
• Assists with the creation of standard operating procedures for the documentation of treatment guideline development processes
• Conducts literature searches
• Ensures timely response, review, and submittal of customer and project-level inquiries
• Creates and implements detailed administrative operational project plans
• Performs assignments independently but may be subject to supervisory or appropriate project staff oversight as needed
• Composes and edits various program and scientific communications and documents, including spreadsheets, presentations, and other communications
• May assists in the preparation of reports, including writing of semi-annual and annual reports, quarterly reports, and other project report requirements
• May provide logistical operation oversight and support for the life cycle of project procurements
• May travel domestically or internationally (10%)
• This position is located in Frederick, Maryland 

BASIC QUALIFICATIONS

• Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in health sciences, clinical research, or a related field or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency.
• In addition to educational requirements, a minimum of two (2) years of relevant program management/ logistical support experience
• Ability to work in a fast-paced clinical research setting, both independently and within a team
• Effective communication and strong organization skills
• Excellent writing and editing skills
• Proficient in Microsoft Word, Excel, PowerPoint and with cloud content platforms
• Experience managing portions of public health or research programs in resource-challenged settings or with complex diverse research collaborations
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Master's degree preferred
• Excellent research, problem-solving, public speaking, writing, and interpersonal communication skills
• Experience with infectious disease research and scientific terminology
• Five (5) years progressively responsible experience in program management/logistical support

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

#readytowork