Clinical Project Manager I

Job ID: req2619
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
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, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, 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 specialized support for special initiatives and projects in support of the National Institute of Allergy and Infectious Diseases' (NIAID) Division of Microbiology and Infectious Diseases (DMID). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging infectious disease studies globally. All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).

KEY ROLES/RESPONSIBILITIES

• Provides administrative, management, and/or programmatic support, including planning, research, analysis, and correspondence control/communication within the CMRPD
• Supports highly complex domestic and 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
• Works closely with project leaders to manage subcontracts, clinical trials agreements and other vendor agreements which can include the development of Statements of Work, vendor justifications, source evaluation group reports, overseeing and monitoring technical work of the subcontractors, reviewing deliverables and invoices, and monitoring adherence to the agreement scope and budgets
• Assists with the reviewing and processing of site payment reports for clinical trial sites
• Prepares project reports which includes maintaining timelines for the drafting, reviewing, and submission of the reports, collecting and maintaining project status updates, metrics data, operational accomplishments, risks, and works with key contributors to ensure timely compilation of reporting information as needed
• Develops and assists to maintain comprehensive project specific databases, trackers and metrics using various tracking systems such as Microsoft Excel, SharePoint, Smartsheet and other applicable project and program related software
• Communicates and collaborates effectively in writing and verbally with multidisciplinary group of stakeholders and colleagues
• Works independently with guidance and direction, as appropriate
• This position is located in Frederick, Maryland

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 the education requirement, a minimum of two (2) years of progressively responsible experience directly related to this position
• Experience in contract/subcontract management
• Experience in reporting writing
• Must have the ability to manage, organize, and communicate effectively, orally and in writing with program leaders
• Flexibility and willingness to adapt in a fast-paced and changing environment
• Possesses strong interpersonal, leadership, and analytic skills with the ability to prioritize multiple tasks and projects
• Demonstrates good judgment and decision making, must be detail oriented, possess personal accountability, strong administrative abilities, and the ability to handle and prioritize multiple tasks and projects 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
• Demonstrates proficiency in Windows and Microsoft Office Suite, including Word, Excel, and Outlook
• Knowledge of Smartsheet, SharePoint or other project tracking software
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience in health science, clinical trials, or laboratory experience, particularly in infectious diseases
• Experience in overseeing and managing federal contracts/research subcontracts administration/management
• Knowledge of Federal Acquisition Regulations (FARs) and Federal Travel Regulations (FTRs)
• Experience in report writing and metrics tracking

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

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