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All opportunities at Telecare are contingent upon successful completion and receipt of acceptable results of the applicable post-offer physical examination, 2-step PPD test for tuberculosis, acceptable criminal background clearances, excluded party sanctions, and degree or license verification.
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Other / Regulatory: Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and readily adopts new processes and engages in practice operation changes.
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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Works with the manager to collate metrics, analyzes compliance metrics and provides recommendations on updating financial systems.
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Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely manner Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
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Our Project Delivery colleagues within our PPD clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials.
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Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements. Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management.
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Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audit. As a QA Compliance Manager/Senior Compliance Manager, you will conduct complex internal and external audits and process audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.
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Leads complex projects and programs, including full project oversight and maintenance of metrics, compliance, and finances. Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements.
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Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
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Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less sophisticated projects.
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Entes and maintains trial status information relating to SIA activities onto PPD. May work with the start-up CRA(s) to prepare the regulatory compliance review. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and.
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Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS). Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company ("PPD"), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD. Freedom to Act: Assignments are defined in terms of activities and objectives.
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For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
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Trial Activation Approval Specialist I. Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. Essential Functions and Other Job Information: Essential Functions Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.
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