Clinical Project Manager I - REMOTE

Clinical Project Manager I - REMOTE

Job ID: req3801
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 Diseases (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 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 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 the education requirement, a minimum of five (5) years of progressively responsible experience


• 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

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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