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Executes both routine and non-routine business support tasks for the Coding Data Quality area under limited supervision, referring deviations from standard practices to managers. CPC (Certified Professional Coder) or CCS-P (Certified Coding Specialist-Physician) required.
$18.5 - $35.29 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Expertise within CROs and scientific and clinical data/ terminology, and the drug development process. MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.
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Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently. Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
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Minimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.) Minimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.
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College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years experience in GCP regulated industry if not a college graduate. Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc.
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With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharmas international awards programs for the last three consecutive years.
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Requirements:College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduateMinimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.
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Responsible for performing quality inter-rater review audits of medical records coded by internal team (CDQA and Sr CDQA) to ensure the ICD-10 codes that are submitted to the Centers for Medicare and Medicaid Services (CMS) for the purpose of risk adjustment processes are appropriate, accurate, and supported by clinical documentation in accordance with all State and Federal regulations and internal policies and procedures.
$18.5 - $31.72 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop CAPA plans and contribute to resolution of audit findings independently. Understanding of how to plan, prepare and conduct GCP audits independently. Hands-on experience with clinical trial and pharmaceutical development preferred.
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Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada. Proficient with 21 CFR Part 11, FDA, and GxP requirements. Job Specific Skills: Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
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Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates. Reputation as emerging leader in field with sustained performance and accomplishment.
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Proficient in authoring and managing audit documents independently. Expert knowledge of scientific principles and concepts. Good communication skills and willingness to work with others to clearly understand needs and solve problems.
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Good organizational and communication skills. Excellent problem-solving skills. Proficiency with MS Office applications. For more information, visit www. mmsholdings.com or follow MMS on LinkedIn.
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Job Requirements Bachelor's degree in business administration or a related field (OR equivalent job experience) Prior experience with data and document management Computer proficiency and data entry skills Thorough understanding of relevant regulatory frameworks and agencies, as well as compliance best practices Be willing to get Certified Records Analyst (CRA) and/or Certified Information Professional (CIP) certification.
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data quality specialist jobs Title: quality auditor
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