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 services for initiatives in support of the National Cancer Institute (NCI). CMRPD is responsible for establishing and maintaining clinical trials support services for the NCI, Division of Cancer Prevention (DCP). This position may support various institutes of the NIH.

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

• Coordinate development of a core data management resource/database systems
• Develop data management training and support resources for central staff and clinical site staff
• Establish and oversee data quality management processes
• Create and manage data management workflows and project timelines to track progress of data management activities across sites
• Assist with design and oversee coordination of core clinical trial data tasks including: Electronic Case Report Form (eCRF) development, database setup, establish data collection systems based on the specific needs of each protocol, edit check programming, query management, generation of data reports, and materials for site data management training
• Establish strong communication pathways with the data operation team, project managers, statistical support, and other internal and external stakeholders
• Serve as an escalation point-of-contact
• Serve as a subject matter expert for data management activities and staffing as needed
• Oversee development and integration of affiliated data management resources, including randomization systems, medical and drug coding procedures, electronic data importation systems, communication/training portals, etc.
• Develop and implement administrative policies and procedures for the data management core, such as: project/protocol database training records, standard operating procedures/processes and compliance monitoring electronically
• Participate in budget development, cost estimating and forecasting related to data management support services/systems for protocols
• 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
• This position requires approximately 10% travel to domestic locations
• 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 or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of four (4) years of progressively responsible experience, including two (2) years of experience in a manager capacity
• Previous experience managing the delivery of multiple projects through the full data management life cycle
• Thorough knowledge of the data management process (e.g., database design, eCRF development, reconciliation of data queries, 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
• Ability to compile standard and custom data reports
• Knowledge of clinical research regulations including FDA/Good Clinical Practices and relevant data management guidelines
• Working knowledge of clinical research operations, clinical trials, medical terminology, and/or pharmacology
• Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
• Strong skills in MS Word, Excel, and Outlook
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Six (6) years of progressively responsible data management experience in clinical research
• Experience directly managing multiple concurrent projects/systems
• Familiarity with software such as, Medidata Rave, REDCap, SAS, and R
• Working knowledge of Microsoft Project, Smartsheet or other project tracking software
• Clinical Research or Project Management Professional with oncology experience
• Clinical database operations experience at a CRO or Sponsor
• Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs) ICH, and relevant regulatory agency requirements domestically and internationally
• Knowledge of the development of electronic Trial Master Files
• Familiarity with Federal Acquisition Regulations (FAR) and experience conducting federally funded research studies
• Familiarity with Federal Information Security Modernization Act (FISMA)
• Experience in overseeing the work of subcontractors and/or vendors
• Detail-oriented and possess excellent skills in prioritization, problem solving, organization, decision-making, time management and planning
• Exceptional written and oral communication skills to work closely with numerous stakeholders from diverse organizations, attend meetings as a program liaison, and keep track of meeting minutes
• Ability to work in a clinical research setting both independently and within a team
• Demonstrated success in previous positions in deployment and implementation of a clinical data management system and processes

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

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