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