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Reports to: Associate Director, Clinical Document Management (Statistics and Quantitative Sciences) The Sr. Manager of Clinical Document Management and Inspection Readiness will provide support for Trial Master File (TMF) and inspection readiness (IR) activities to the Clinical Document Management team and to internal and external clinical study team members and functional areas.
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Experience with Documentum, BlueCielo, or SAP document database systems for efficient document control and man. Utilize document database systems such as Documentum, BlueCielo, or SAP to man.
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Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Good Clinical Data Management Practices (GCDMP) At least 5-7 years of experience as a Senior or Lead Clinical Data Manager leading clinical data management activities for multiple studies or a clinical program(s) including oversight of multiple CROs and vendors.
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B.S. Degree in engineering or Associate degree in engineering or construction, project management experience for at least three years of progressively responsible experience in office and field engineering, project management, construction required, and inspection.
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Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good manufacturing practices (GMPs.
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Utilize the hospital and Radiation Oncology EMR systems to record patient treatment delivery, document patient positioning information, and communicate any pertinent information regarding the patients care coordination.
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Familiarity with Information Governance technology ecosystem and how it supports Information Governance processes including: enterprise content / document management systems, records management systems, archival systems, legal hold management systems, mobile device management systems, communication surveillance applications, privacy compliance management systems, data discovery and scanning, etc.
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Document outreach and outcomes in Starfish and refer students to campus resources when appropriate. Strong organizational and time management skills with exceptional attention to detail required.
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The Program Manager position will directly report to the Physician Leader of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU)- Leukemia Research Team and indirectly report to the ACC CRU Associate Director Research Operations.
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Strong knowledge of vulnerability management tools (Aqua, Palo Alto Prisma, Wiz, CrowdStrike, Tenable Nessus, or Qualys preferred) With a focus on vulnerability management, container security, and other related areas, the ideal candidate will have 5+ years of experience in cloud security and a strong understanding of cloud computing concepts and technologies.
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Provides transitional care management. We offer integrated managed care products, pharmaceutical benefit management and specialty pharmacy services, behavioral health services, and other administrative services.
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Must haves: Recruit, Screen, Enroll subjects in to clinical trails Explain Informed Consent process Document adverse events Collect study documents, protocols, regulatory documents, informed consents, case report forms and source documents Prepare the Institutional Review Board, IRB applications.
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Asha V. George, Director Integrated Case Management ageorge@phmc.org. Provide case management and behavioral health screenings to individuals who are incarcerated and who have reentered into the community in Delaware County.
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Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. Elekta Unity MR Linear Accelerator.
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Minimum of 1 year experience with Document Control within a GXP environment, with specific familiarity with Trial Master File and Quality Management System controlled documents. Demonstrated knowledge of document control systems, preferably electronic systems.
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document management jobs Title: clinical research associate Company: Parexel in Philadelphia, PA
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