Clinical Project Manager I
Job ID: req1408
Employee Type: exempt full-time
Facility: Frederick: Ft Detrick
Location: PO Box B, Frederick, MD 21702 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.
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 essential program/project management expertise to support the comprehensive technical work for the NIAID Division of Intramural Research, NIAID Division of Clinical Research, CMRPD Project Management Office and Regulatory Compliance and Human Subjects Protection Program (RCHSPP), in addition to other initiatives and is responsible for performing comprehensive project and programmatic planning, research, subcontracting, analysis, communication and liaison activities.
- Serves as one of the CMRP project leads and as a liaison between various Leidos Biomed, NCI and NIAID entities and collaborating offices, interacting with both scientific and administrative officials
- 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
- Oversees and monitors the technical work of subcontractors and performs review and verification of subcontractor deliverables and invoices
- Performs work independently with guidance and direction provided by the CPM II, as appropriate
- Provides insight guidance into current Good Clinical Practices and application to clinical research projects
- Provides insight and guidance into applicable FDA regulations, ICH and other international specific country regulations as applicable to clinical research projects
- This position is located in Frederick, Maryland
- 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 or four (4) years related experience in lieu of degree
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to education requirements, a minimum of six (6) years related experience in a pharmaceutical, biotechnology and/or clinical environment
- Ability to effectively communicate, both verbally and in writing, with demonstrated expertise in grammar, syntax and format
- Strong problem solving, planning and organizational skills with the ability to prioritize multiple tasks and projects
- Strong data collection and writing/editing skills with ability to function independently or collectively within a team setting in the production of high-quality deliverables compliant with established guidelines, practices, and procedures related to medical writing
- Must be detailed-oriented
- Previous project management and/or study coordination experience including data management and subcontracting
- Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)
- Knowledge of clinical trial fieldwork concepts and practices
- Must be able to obtain and maintain a security clearance
- Experience with grants, contracts and research subcontracts
- Cancer and infectious disease research experience
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)