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Clinical Outcomes Solutions

Senior Medical Coder

Clinical Outcomes Solutions

. Perform complex medical coding for adverse events, medical history, procedures, and concomitant medications using MedDRA and WHODrug dictionaries .

Posted 11/12/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in medical coding using MedDRA and WHODrug dictionaries, ensuring accuracy and compliance with regulatory guidelines. Proficient in collaborating with clinical teams and managing coding-related data issues across multiple therapeutic areas.

Highest-signal resume keywords
Medical Coding ExperienceProficient In Medidata RAVEStrong Knowledge Of MedDRAUnderstanding Of ICH-GCPAttention To Detail

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Medical CodingAdverse Event CodingData ValidationCoding ConventionsCoding Metrics PreparationVersion ControlUpdate ManagementData CleaningSignal DetectionRegulatory Submissions
Soft Skills
Analytical Problem-SolvingEffective CommunicationCollaboration
Tools & Technologies
Medidata RAVECoder
Industry Keywords
Clinical ResearchFDA GuidelinesEMA GuidelinesGlobal Regulatory GuidelinesTherapeutic Areas

About the role

Key responsibilities & impact
  • Perform complex medical coding for adverse events, medical history, procedures, and concomitant medications using MedDRA and WHODrug dictionaries
  • Review and validate coding performed by other coders to ensure consistency and accuracy
  • Identify ambiguous or unclear terms and query clinical sites for clarification
  • Maintain coding conventions and ensure alignment with study-specific and sponsor requirements
  • Conduct ongoing coding checks during data cleaning cycles and prior to database lock
  • Participate in the resolution of coding discrepancies, queries, and coding-related data issues
  • Review safety data for coding accuracy in collaboration with medical monitors and safety teams
  • Assist in preparing coding-related metrics, reports, and quality documentation
  • Participate in vendor oversight activities when coding tasks are outsourced
  • Stay current with updates to MedDRA and WHODrug dictionaries and communicate relevant changes to project teams
  • Work closely with clinical data management to ensure proper term collection and standardization
  • Partner with safety teams to support expedited reporting, signal detection, and regulatory submissions
  • Support biostatistics and medical writing with queries related to coded terms for analyses and study reports

Requirements

What you’ll need
  • Proficient in Medidata RAVE and Coder
  • Strong working knowledge of MedDRA and WHODrug dictionaries, including version control and update management
  • Bachelor's degree in life sciences, nursing, pharmacy, public health, or equivalent healthcare background
  • 2 years of medical coding experience in clinical research
  • Experience supporting multiple therapeutic areas
  • Excellent understanding of ICH-GCP, FDA, EMA, and other global regulatory guidelines
  • Strong attention to detail, analytical problem-solving, and ability to manage multiple projects simultaneously
  • Effective communication skills and experience collaborating in matrixed research environments