Clinical Project Manager II, Operations (REQ1298)
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POST DATE 8/2/2020
END DATE 8/7/2020
Frederick National Laboratory
JOB DESCRIPTIONClinical Project Manager II, Operations
Job ID: req1298
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.
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, tuberculosis, malaria and other infectious diseases and viruses such as hepatitis C 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 initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID). CMRPD is responsible for establishing and maintaining clinical management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging infectious disease studies. All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO). This position may support various divisions of NIAID.
Responsibilities include but are not limited to:
* Provides clinical operations management for domestic and international clinical trials and special projects
* Works closely with program and project leadership to implement clinical trials, including developing overarching project plans with scope and timelines, setting expectations for operational performance of subcontractors
* Provides coordination and technical expertise in the implementation and execution of the clinical studies
* Manages project risk by proactively anticipating obstacles and developing contingency plans and solutions
* Ensures appropriate communication plans are in place to facilitate and maintains communication among scientific, regulatory, safety, monitoring, laboratory, and subcontracts project team members
* Manages interactions with CROs and other vendors as well as with domestic and international site staff
* Manages protocol-related document translations
* Participates in budget development, cost estimating and forecasting
* Collates, reviews, and analyzes metrics to ensure key clinical trial project timelines are met, and identifies trends and opportunities for improvement
* Provides input and acts as part of the team that manages/monitors ancillary activities such as protocol development, manual of operations development, data management processes including Case Report Form (CRF) development, biospecimen management, laboratory kit design, and study supply management including ordering, tracking and labeling
* Maintains extensive knowledge and understanding of international and domestic clinical research regulations and compliance requirements
* Reviews and/or develops operational processes, procedures, and documents required to manage projects effectively, including study planning, start up, implementation and close out
* Provides input for training materials for delivery to research staff and study teams on conference calls and in-person at investigator meetings
* Manage subcontractors including the development of Statements of Work, review and approval of deliverables, review of invoices, and monitoring of scope and budgets
* May supervise other operational project staff, and may be asked to perform other related duties as assigned by a responsible authority
* Position will travel 10-20% domestically and internationally
* Position is located in Frederick, Maryland.
* Prepares and reviews progress reports
* 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
* A minimum of eight (8) years of progressively responsible, relevant experience in clinical research, including a minimum of three (3) years directly managing multiple concurrent clinical projects
* Extensive experience in contract management and reporting
* Previous project management and/or study coordination experience including data management and 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 be able to obtain and maintain a clearance
* Clinical Research or Project Management Professional with infectious disease experience
* Clinical operations experience at a CRO or Sponsor
* Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
* Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
* Knowledge of the development of electronic Trial Master Files
* Familiarity with the management and shipment of study products and supplies
* Familiarity with Federal Acquisition Regulations (FAR) and experience conducting federally funded research studies