IT Systems Manager III

Job ID: req3480
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) and the Regulatory Compliance Human Subjects Protection Program provides (RCHSPP) provides clinical trial management support to the National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Operations (OCRPRO).

KEY ROLES/RESPONSIBILITIES

• Provides comprehensive information technology (IT) and systems support to the Clinical Monitoring Research Program Directorate (CMRPD) Deputy Director in providing leadership, direction, and strategic planning for assigned programs, projects, and task orders of the Frederick National Laboratory for Cancer Research (FNLCR)
• Responsible for the alignment of IT systems to organizational objectives, establishment of budgets and cost models, implementation of service and change management methodologies, and evaluation/integration of new technologies
• Allocation and management of staff and IT infrastructure to support business operations within CMRPD. Provide ongoing direct and indirect leadership, support, oversight, and technical guidance to both National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID) and other agency initiatives, including National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Heart, Lung, and Blood Institute (NHLBI), Clinical Center (CC), and various subcontractors
• Partners closely with internal/external enterprise architecture and technology groups to define CMRPD needs and identify integrated and collaborative approaches to solutions
• Actively serves as a member of management teams and advisory committees
• Serves as HIPAA/HITECH Compliance Officer. Review all HIPPA/HITECH incident reports received, ensure appropriate corrective actions and preventative actions are taken
• Oversees the CMRPD Document Control Group, which maintains contractual and regulatory documents for clinical research studies and manages electronic document records management systems, maintains departmental controlled documents, and facilitates regulatory review of clinical protocols and revision of controlled documents
• Serves as IT representative for CMRPD for collaboration with FNLCR Operations and other NIH institutes technology groups, including NIAID Office of Cyber Infrastructure and Computational Biology (OCICB), NCI Center for Biomedical Informatics and Information Technology (CBIIT), NIH Center for Information Technology (CIT), and the Leidos Biomed Enterprise Information Technology (EIT)
• Leads development of administrative and information technology related policies, procedures, product evaluations, and capacity planning; provides guidance and recommendations on to CMRPD senior leadership
• Serves as CMRPD technical lead and subject matter expert in selection and integration of new technologies, clinical data management systems, and electronic health records for new task orders
  Responsible for improving information systems efficiency, accessibility, and connectivity regardless of source, format, location, or resource availability
• Directly supervises and manages direct reports in the completion of day-to-day tasks and responsibilities for multiple technical projects; set priorities based on customer defined priorities
• Participates on committees, task forces, and working groups; attend seminars and workshops to maintain awareness of best practices and new developments that could impact the business
• This position is located at 5705 Industry Lane, Frederick, Maryland, 21704 with the ability to work remotely
  
  

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 or university according to the Council for Higher Education Accreditation (CHEA). Additional qualifying experience may be substituted in lieu of required education. Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of eight (8) years of information technology and systems management experience including six (6) years of experience leading complex technical project teams and supervising staff
• Demonstrated proficiency in one or more high-level computer languages
• Broad range of knowledge of information systems, technical infrastructure, and ability to innovatively fulfill project requirements utilizing a small technical team
• Ability to successfully lead a team in the completion of assigned projects and task orders per performance standards
• Ability to lead, guide, manage, and mentor a team including the development of competency and capabilities
• Knowledge of organizational business practices and contract operations including budgeting and financial management, operations and program administration, government regulations, scientific operations, project management
• Excellent communication skills including technical writing experience and ability to interface at a technical level with research, clinical, administrative, and information technology staff
• Ability to effectively manage and resolve conflict and customer concerns
• Ability to lead, manage, organize, and interact effectively with other members of senior management
• Ability to apply effective leadership and interpersonal skills by use of strategic thinking, team and project leadership, personnel development, and decision-making
• Ability to excel in fluid working environments and to adapt to changing priorities
• Some domestic and/or international travel required.
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Demonstrated senior level experience leading and providing information technology program/project management for complex business, regulatory, and clinical research initiatives
• Minimum of five (5) years-experience in an information technology leadership role in a life-sciences, pharmaceutical or biotechnology environment
• Familiarity and experience with federal government programs
• Experience in subcontract management, from initiation through post-award administration, including authoring statement of work documents, responding to solicitations, and managing multimillion dollar budgets
• Ability to independently manage and prioritize multiple complex projects
• Ability to clearly communicate independently and collaborate across divisions and programs and with numerous external stakeholders
• Familiarity with cGxP regulations, federal information security compliance requirements, and federal standards governing information systems
• Experience in utilization of software as a service or hosted platforms to facilitate rapid deployment
• Demonstrated ability in leading global information systems delivery and communications technologies in support of clinical research networks
• Familiarity with clinical data management systems

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

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