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Document Control Manager

Company: Frederick National Laboratory for Cancer Research
Location: Frederick
Posted on: August 27, 2019

Job 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)/Regulatory Compliance and Human Subjects Protection Program (RCHSPP), OCRPRO provides regulatory, clinical trials management, pharmacovigilance, protocol development/navigation and program management support to the National Institute of Allergy and Infectious Diseases' (NIAID's) Intramural Clinical Research Community. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Oversees functions of the Document Control (DC) group supporting operations of CMRPD's RCHSPP Establishes and maintains procedures governing the lifecycle of Standard Operating Procedures (SOPs) and other regulatory and administrative documents within each functional area of the RCHSPP (i.e., clinical safety, clinical trials management, regulatory affairs, protocol navigation, information technology, and general administration) Coordinates auditing of all regulatory and administrative documents against master files Generates audit reports and resolves any deficiencies identified Develops and maintains accurate and secure filing systems for documentation to include current active/effective documents/forms, inactive documents/forms, and obsolete documents/forms, inclusive of the historical information Establishes procedures for the issuing, tracking, and reconciliation of documentation Generates and manages controlled documents (e.g., SOPs, Investigational New Drug [IND] applications, and study documents) Leads and provides oversight of vendor contracts for onsite and offsite storage of controlled documents Serves as DC subject matter expert and active participant in the development and implementation of new, or modifications to existing electronic document and records management systems. Participates in organizational management meetings to provide input from a DC perspective and serves on planning committees Develops and tracks progress of group-specific goals and provides content for reporting requirements Facilitates the dissemination of information related to current projects to appropriate management and subordinate staff Establishes work assignments, oversees performance management, and provides direction and supervision to DC staff This position is located in Frederick, Maryland BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (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, a minimum of four (4) years of relevant experience is required Demonstrates working knowledge of department specific documentation systems and regulations in a Current Good X Practice (cGxP) environment Possesses knowledge of Food and Drug Administration (FDA) regulations and guidelines for International Conference on Harmonization/Good Clinical Practices (ICH/GCP) Proficiency in Microsoft Office Suite and experience working with Electronic Document and Records Management Systems (EDRMS) Prior supervisory experience Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Three plus (3+) years of experience supervising or leading teams or projects Familiarity with TrackWise quality management software and/or the OpenText Content Suite platform Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

Keywords: Frederick National Laboratory for Cancer Research, Frederick , Document Control Manager, Other , Frederick, Maryland

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