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Medical Coder
Clinical Outcomes SolutionsMedical Coder ensuring accurate medical coding for clinical trials within pharmaceutical clients. Collaborating cross-functionally to maintain high-quality data meeting global regulatory standards.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
medical codingMedDRAWHODrugcoding validationdata cleaningcoding discrepancies resolutioncoding metrics preparationterm collectionsignal detectionregulatory submissions
Soft Skills
attention to detailanalytical problem-solvingproject managementeffective communicationcollaboration
Tools & Technologies
Medidata RAVECoder
Industry Keywords
clinical researchCROpharmaceuticalbiotechICH-GCPFDAEMAtherapeutic areasoncologyrare disease
Tech Stack
Tools & technologiesGoogle Cloud Platform
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 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
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; advanced degree preferred.
- **2 years of medical coding experience in clinical research**, ideally within CRO, pharmaceutical, or biotech environments.
- Experience supporting multiple therapeutic areas; oncology, rare disease, or immunology experience preferred but not required.
- 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.
Benefits
Comp & perks- 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; advanced degree preferred.
- **2 years of medical coding experience in clinical research**, ideally within CRO, pharmaceutical, or biotech environments.
- Experience supporting multiple therapeutic areas; oncology, rare disease, or immunology experience preferred but not required.
- 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.