Medical Coder
Clinical Outcomes Solutions
full-time
Posted on:
Location Type: Remote
Location: South Africa
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Tech Stack
About the role
- 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 the preparation of 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
- Bachelor's degree in life sciences, nursing, pharmacy, public health, or equivalent healthcare background; advanced degree preferred.
- 2 years of medical coding experience in clinical research, ideally within CRO, pharmaceutical, or biotech environments.
- Strong working knowledge of MedDRA and WHODrug dictionaries, including version control and update management.
- Experience supporting multiple therapeutic areas; oncology, rare disease, or immunology experience preferred but not required.
- Proficient in Medidata RAVE and coder.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical codingMedDRAWHODrugcoding validationdata cleaningcoding discrepancies resolutioncoding metrics preparationterm standardizationsignal detectionregulatory submissions
Soft Skills
attention to detailanalytical problem-solvingproject managementeffective communicationcollaboration