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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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Extensive knowledge and ability to contribute in the areas of professional quality standards, data privacy, data integrity and data governance. Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
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This position also supports coordination across all shared services and vendors to assure data integrity and data validation processes are in place. Position SummaryAs a Manager, Business Consulting within the Revenue Integrity COE organization, you will be leading Risk Adjustment technical activities, not limited to electronic medical record data extraction, reconciliation and aggregation, and financial and operational reporting.
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Minimum three years’ experience performing various claims validation reviews in a multi-specialty outpatient/Ambulatory Surgery Center is strongly preferred. Primarily, the scope of audits and reviews will be in the areas of coding, billing, medical record documentation, claims, clinical data, and reports as they relate to the revenue cycle.
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Provides technical expertise in database design tools and methodologies, data validation methodologies, data migration processes, file organization, indexing methods, data integrity, and security procedures, and backup and disaster recovery planning.
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Monitor billing accuracy, compliance issues, and structure: ensure data integrity through interaction with financial and outcomes systems and auditing verification; assists in investigating and responding to billing audits.
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Collaborate with data engineers to understand data pipelines and design validation checks that complement and ensure the integrity of these pipelines. Expertise in data visualization tools (e.g., Tableau, Power BI) to present data validation results and insights.
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Data Conversion Assistance: Guide clients in the conversion of legacy data, overseeing mapping and validation processes to maintain data integrity. We offer a consulting-led, integrated portfolio of Information Technology, Project Management, Business Portfolio Systems, Infrastructure, Engineering, Assurance, Eco-Sustainability, Connected Marketing, Cloud, Mobility, Big Data, and Analytics services to a broad base of clients spanning across multiple industry verticals including California Utilities clients and customers.
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You should be familiar with analog and digital circuit design, flexible and rigid PCB design, signal integrity and power integrity evaluation, lab validation and equipment, and electrical failure analysis.
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At least eight (8) years of experience in auditing and/or experience in a senior advisory role in quality management and/or at least twelve (12) years of professional experience in the pharmaceutical industry in a relevant Medicine function (Pharmacovigilance, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics and Data Management, computer system validation.
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The CSV Senior Engineer / Manager will partner with Business Owners, Technical Owners and Quality to create, manage, and improve computerized systems validation deliverables for electronic systems (including data management), applications and associated controls to maintain data integrity supporting ALCOA+ principles throughout the validation lifecycle.
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Validate and maintain all inventory management and data integrity routines. Leadership skills including: Excellent customer experience behaviors, a strong sense of urgency, attention to detail, creative problem solving and sound decision-making skills that align with strategic initiatives, effective delegation and validation, and the ability to execute daily priorities efficiently.
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Maintains accuracy in abstraction by following published guidelines and abstraction specifications; maintain accuracy and integrity of audit information by following standards and guidelines; facilitates and participates in quality assurance audits of abstracted/audited data to ensure a high level of inter-rater reliability among the clinical data abstractor team and achievement of acceptable validation results from external audits.
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Utilize 3D laser scan point cloud data to generate 3D Models, 2D Isometrics, perform P&ID / PFD validation. Enter provided data into mechanical integrity data management system.
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The Data Quality Manager ensures the accuracy, integrity, and compliance of clinical data within our organization. Identify opportunities for process improvement in data collection, entry, and validation to enhance overall data quality.
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