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Job DetailsLevel: ExperiencedJob Location: National Institutes of Health (NIH) - Main Campus/Bethesda - Bethesda, MD 20892Position Type: Full TimeEducation Level: Bachelors DegreeSalary Range: $1.00 - $2.00 Salary/yearTravel Percentage: NoneJob Shift: DayJob Category: Information TechnologyPosition Objective: The purpose of this task is to provide quality management services in support of core task Enterprise Product Management. This will include the validation of NIAID Enterprise Clinical Informatics Systems in compliance with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) requirements, e.g. 21 Code of Federal Regulations (CFR) Part 11. The Contractor will comply with the CIB/ECIS Quality Management System (QMS) that is based on GAMP 5. Duties and Responsibilities: Responsible for a variety of Computer Systems Validation/Assurance activities and tasks. Updating CIB systems to support health authority requirements. Developing processes and procedures to support regulatory compliance requirements. Supporting initial and periodic Validation/Assurance of NIAID CIB Enterprise Clinical Informatics Systems. Responding to validation findings and taking corrective actions. Supporting health authority inspections. Conducting activities to maintain the validated state of NIAID CIB Enterprise Clinical Informatics Systems. Maintain the Computer Systems Validation/Assurance of the servers and the software to ensure that the systems are compliant. Comply with requisite FDA and other applicable international requirements for clinical research protocols. Manage and document the access privileges for all users that access the NIAID Enterprise Clinical Informatics Systems in compliance with documented standard operating procedures (SOP), which shall be provided to the Contractor upon award. Manage use of process improvement, reengineering methodologies, and internet-related methodologies and principles to conduct process modernization projects. Responsible for transitioning of existing organizations or project teams in accomplishing the organization’s goals or project activities and objectives through improved use of internet and other automated processes. Support activity and data modeling, development of modern business methods, identification of best practices, and creating and assessing performance measurements. Provide group facilitation, interviewing, training, and additional forms of knowledge transfer. Serve as key coordinator between customers and multiple project teams to ensure enterprise-wide integration of reengineering efforts and application of best practice including e-business practices. May provide daily supervision and direction to other contractor business reengineering specialists and web architects. QualificationsBasic Qualifications: Bachelor’s Degree is required Requires six years of relevant experience Preferred Qualifications: Ability to communicate effectively, orally and in writing, with non-technical and technical staff Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects Prior experience with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) requirements, e.g. 21 Code of Federal Regulations (CFR) Part 11 is preferred Prior experience working with Quality Management Systems is preferred. *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.
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