Leidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.
The breadth of FNLCR’s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes. LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.
For more information about Leidos Biomedical Research Inc., please visit our webpage at http://www.leidosbiomed.com/
Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP’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. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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. CMRP’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 (CMRP) provides support to the National Institute of Allergy and Infectious Diseases (NIAID) Biostatistics Research Branch (BRB) within the Division of Clinical Research (DCR).
The Senior Clinical Data Project Manager: 1) drives development and implementation of data management standard operating procedures in coordination with the study-specific data manager, 2) develops data management workflows to describe roles, responsibilities and activities required to ensure data completeness and accuracy, 3) creates and manages project timelines to track progress of data management activities, determine resource needs and identify of scope work, 4) coordinates with project team to address delays or resource constraints, 5) generates reports to evaluate data quality in an ongoing manner, 6) coordinates with study-specific data managers and statisticians to develop and implement strategies to improve data quality, 7) oversees coordination of core clinical trial data tasks including: Case Report Form (CRF) development, development of edit checks and generation and resolution of data queries, 8) establishes strong communication pathways with the data operation team, project managers, statistical support and other internal and external stake holders, 9) serves as the escalation point of contact for unresolved data issues, 10) ensures effective communication between principal investigators, study statistician, statistical research team and the data center operation to ensure the appropriate design, collection, storage and delivery of data assets are consistent with organizational priorities, 11) assists in identifying appropriate qualified vendors and works closely with project managers and data managers to ensure accuracy, completeness and timeliness of data processing when data management responsibilities are outsourced to a contract research organization, and 12) will travel up to 10% (domestically/internationally) including travel to high risk locations.
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 health, clinical, biological or mathematical sciences, or related field or four (4) years related experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
A minimum of four (4) years direct data management experience, including at least three (3) years as a clinical data management project lead
Previous experience managing the delivery of multiple projects through the full data management life cycle
Thorough knowledge of the data management process (e.g., serious adverse event reconciliation, management of local laboratory data)
Knowledge of data management operating procedures and the ability to generate and apply them in practice
Knowledge of clinical research regulations including Good Clinical Practices and relevant regulatory guidelines
Working knowledge of clinical research operations, clinical trials, medical terminology, and/or pharmacology
Excellent communication, interpersonal and teamwork skills with the ability to establish and maintain effective working relationships with coworkers and collaborators
Strong project management, organization and problem-solving skills
Ability to work independently with available resources
Ability to travel up to 10% (domestically/internationally) including travel to high risk locations
Project Management Professional (PMP) certification
Familiarity with DataFax, OpenClinica, Oracle Clinical, SAS, and R
Interest in infectious disease research