Associate Clinical Project Manager I

Job ID: req2530
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., 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.

The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging infectious disease studies globally. All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

• Provides programmatic support and coordination to various research projects
• Performs project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate program objectives
• Communicates and interacts with high-level executive, administrative, technical and program management staff, both internally and externally, to gather and compile information for dissemination
• Creates and maintains various tracking systems using Microsoft Excel, SharePoint and other applicable project and program related software
• Assists in the collection and compilation of metrics data and operational accomplishments in support of Leidos Biomed reporting requirements
• Prepares and/or assembles presentations, background information and related materials and information for meetings
• Works closely with project leaders and project teams to manage expectations
• Works independently with guidance and direction, as appropriate
• Participates in the execution of projects and provides programmatic and technical support in the development of administrative and operational processes, templates, procedure manuals, and other documents
• Provides support to the development and implementation of various operational plans and technical/logistical tracking systems to meet research and operational needs
• Provides support for various subcontract planning, development, and implementation activities, including preparing statements of work, evaluating proposals including pricing, monitoring budgets, and assisting the technical representative for subcontract management oversight for assigned activities
• Assist with the development of payment models for clinical trials sites
• Interacts with auditing and monitoring agencies to facilitate the exchange of information
• Works closely with project leaders to oversee and monitor the technical work of subcontractors, and perform reviews and verification of subcontractor deliverables and invoices
• Coordinates project deliverables and reports on project milestones, budget utilization, timelines, resource requirements, and risk assessments
• Develops and manages core project management documents such as project charters, project plans, communication plans, schedules, resource charts, reports, timelines, etc.
• Plans, coordinates and tracks project activities on both an individual project and program level
• Monitors progress against plans and key deliverables
• Assists clinical research teams in the development of protocol specific plans that adhere to the International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), the National Institutes of Health (NIH) Standards of Clinical Research, U.S. and international regulations
• Supports the coordination of communication between research operations, program management, project stakeholders and team members, and between government customers and subcontractors
• Works collaboratively with clinical project managers to develop monthly, quarterly, semi-annual and annual project/program progress reports and corporate contract status reports
• Coordinates team meetings and assists in the development of meeting agendas, presentations materials and summary reports
• Prepares and reviews internal progress reports
• Reviews meeting minutes and action items to ensure information is captured accurately
• Position may travel 10% domestically and internationally
• 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 (Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency
• No experience beyond a bachelor's degree is required
• Ability to perform and organize administrative processes to effectively and efficiently manage daily operations and coordinate program planning
• Ability to work in a clinical research setting both independently and within a team
• Thorough understanding of the clinical research environment
• Must be detail-oriented with 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
• Proficiency in Microsoft Office Suite including Visio and PowerPoint
• Flexibility and willingness to adapt in a fast-paced and changing environment
• Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
• Knowledge of clinical trial fieldwork concepts and practices with a specific focus on international clinical research guidelines related to site management requirements
• Must be willing and able to travel internationally
• Strong organizational skills with the ability to prioritize multiple tasks and projects
• Demonstrates good judgement and decision making, attention to detail, personal accountability, administrative abilities, and the ability to handle multiple tasks and priorities effectively
• Ability to create and maintain a full spectrum of program/project management documents
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience related to clinical trials operations
• Demonstrated success in previous positions in deployment and implementation processes
• Experience managing multiple concurrent clinical trial projects in a pharmaceutical, biotechnology and/or clinical environment
• A Clinical Research or Project Management Professional with infectious disease experience
• International clinical research project support experience
• Familiarity with the management of study products and supplies and experience conducting federally funded research studies
• Experience overseeing and/or reviewing the work of subcontractors and/or vendors

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

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