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Job Description
Precision Medicine Group is seeking a Senior Medical Coder to provide coding in both MedDRA and WHODRUG dictionaries for assigned studies. The Senior Coder will follow Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines. This position will perform Coding quality reviews and work closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner. They will also focus the medical coders as a senior coder.
  • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG)
  • Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
  • Backup the Coding manager for oversight of the team
  • Perform quality control of Coding
  • Provide input into Coding timelines for overall deliverables
  • Ensure that clinical data coding deadlines are met with quality
  • May assess resource needs for assigned projects, as needed
  • Review/feedback from all stakeholders
  • Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed
  • Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation
  • Train clinical research personnel on the study specific Coding related items as needed
  • Review and query coding data according to the Data Management Plan and Coding standards
  • Run coding status and metric reporting
  • Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities
  • Trains and ensures that all data management project team members coding have been sufficiently trained
  • Communicate with study sponsors and project teams as needed regarding coding
  • Present any coding demonstrations/trainings, department/company training sessions, project meetings
  • Perform other duties as assigned
  • 5+ years’ experience within Data Management
  • Bachelors within scientific/science background and combination of related experience
  • 5+ years performing Dictionary medical coding (MedDRA and WHODrug)
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
  • Able to handle a variety of data management task and oversight
  • Excellent organizational and communication skills
  • Professional use of the English language; both written and oral
  • Basic knowledge of drug, device and/or biologic development and effective data management practices
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