Clinical Research Finance Manager I

Job ID: req3524
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 the Frederick National Lab 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

• Provides primary oversight of financial operations and staff across all institutes supported by CMRPD
• Hires, trains, mentors, and manages multiple levels of financial management staff
• Establishes and monitors team goals and performance
• Establishes minimum competencies for staff, conducts performance evaluations and implements corrective action
• Maintains staffing reports by project, by person, and by position
• Develops and maintains financial operations processes and procedures
• Communicates with the Director, senior management, internal CMRPD program staff, and government project officials
• Collaborates with Leidos Biomed Financial Planning & Analysis group on Contract deliverables
• Oversee the preparation and review of project budgets and project identification numbers
• Oversees the preparation of annual budget assumption documents with up-to-date information to track for actuals, approvals, and estimates at completion details
• Performs technical analysis to determine present and future financial performance
• Oversees the preparation of budget documentation and conducts regular reviews to ensure the accuracy and completeness of these records
• Reviews, monitors, and analyzes cost proposals including budget development and business volume preparation
• Develops labor charging instructions
• Oversees change management actions impacting project budgets
• Oversees the preparation of various project and directorate level financial reports including labor analyses, annual and multi-year projections, and estimates at completion
• Oversees analysis of multiple funding sources for determination of proper cost allocation
• Oversees the preparation and review of recommendations for financial plans, acquisition activity, trended future requirements, operating forecasts, etc.
• Oversees the close out of expiring task orders
• Oversees and monitors the approval of purchase requisitions, blanket orders, and credit card purchases, provides approval when needed
• Oversees and monitors the approval of credit card statements, provides approval when needed
• Oversees and monitors the approval of costs related to new/proposed contracts, modifications/amendments, and invoices for financial verification, provides approval when needed
• Leads financial meetings with government customers
• Tracks team deliverables and action items to ensure completion
• Contributes to development of annual report narrative

BASIC QUALIFICATIONS

• Possession of a bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a scientific discipline. (Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency

• In addition to the educational requirements, four to six (4-6) years progressively responsible job-related experience, plus two to four (2-4) years in a management role
• Progressively responsible experience must demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level
• Experience managing financial staff at various levels
• Experience writing proposal business volumes
• Demonstrated experience with analysis of budgets and costs, including burn rates and cost projections
• Demonstrated financial management knowledge and experience in the biotech, pharmaceutical, or clinical research industry
• Demonstrated ability of budgeting and cost tracking
• Ability to collect and disseminate information in a clear, concise manner
• Ability to create Excel and database reports
• Ability to track multiple projects concurrently
• Strong working knowledge of MS Office Suite including Excel (advanced), PowerPoint (intermediate), and Word (intermediate)
• Excellent research and investigative/financial auditing skills with a high degree of accuracy and attention to detail
• Demonstrated budgetary and strategic planning experience and responsibilities as it relates to clinical research
• Ability to review complex documents independently and/or in collaboration with clinical research managers, and determine sufficiency of financial documentation
• Knowledge of study design, clinical and biospecimen terms used in research studies and scientific and medical concepts and terminology
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Knowledge of governmental regulations including Federal Travel Regulations and Federal Acquisition Regulations
• Experience working in a federal contracting environment
• Familiarity with severable and non-severable funding mechanisms
• Knowledge of human subjects protection and/or clinical research activities
• Experience in developing budgets for locations outside of the United States

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
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