Clinical Trials Data Operations Lead

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.

KEY ROLES/RESPONSIBILITIES

The Clinical Monitoring Research Program Directorate (CMRPD) collaborates with various departments on the design, documentation, testing and implementation of clinical data studies.

• Completes protocol analysis to generate study database design specifications including CRF/eCRF design, visit schedule, edit checks, system notifications, query logic, user role setup, randomization triggers, supply triggers, and medical coding
• Plans and leads database setup activities, ensuring appropriate database documentation
• Develops data management SOPs as well as clinical trials data management best practice guidelines
• Creates visit schedules within the system to define user workflow
• Programs edit checks to guide users through data entry and prevent erroneous data entry and values
• Ensures, reviews and quality control against associated project protocol, NIAID requirements, CRF standards templates, Good Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards
• Oversees the development of edit checks to guide users through data entry and prevent erroneous data entry and values
• Performs database validation as well as User Acceptance Testing (UAT), and document databases in accordance with programming standards and validation procedures
• Supervises setup and review of data management documentations and operational activities
• Develops clinical data management training and mentorship programs as well as presents at clinical data management training events and workshops
• Acts as a Subject Matter Expert (SME) of clinical data management systems
• Perform demos of systems
• Supervises staff
• This position is located in Rockville, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree in a related field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of eight (8) years relevant experience
• Knowledge of data management processes and systems (specifically clinical data management systems)
• Understanding of clinical trials and the drug development process
• Experience, knowledge, or ability to supervise staff members
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Strong clinical data management capabilities
• Experience with database development/programming
• Excellent communication skills
• Experience with supervision of data management and data entry staff

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