Medical Coder

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Execute intricate medical coding for adverse events, medical history, procedures, and concomitant medications utilizing MedDRA and WHODrug dictionaries.

• Assess and validate coding conducted by fellow coders to guarantee consistency and precision.

• Recognize ambiguous or unclear terminology and consult clinical sites for clarification.

• Uphold coding conventions and ensure compliance with study-specific and sponsor requirements.

• Perform continuous coding checks during data cleaning processes and prior to database lock.

• Engage in the resolution of coding discrepancies, queries, and coding-related data challenges.

• Review safety data for coding accuracy in partnership with medical monitors and safety teams.

• Assist in the development of coding-related metrics, reports, and quality documentation.

• Involve in vendor oversight activities when coding responsibilities are outsourced.

• Keep abreast of updates to MedDRA and WHODrug dictionaries and relay pertinent changes to project teams.

• Collaborate closely with clinical data management to ensure appropriate term collection and standardization.

• Partner with safety teams to facilitate expedited reporting, signal detection, and regulatory submissions.

• Support biostatistics and medical writing by addressing queries related to coded terms for analyses and study reports.

⛳️ Requirements

• 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 a comparable healthcare background; advanced degree preferred.

• 2 years of medical coding experience in clinical research, ideally within CRO, pharmaceutical, or biotech settings.

• Experience in supporting multiple therapeutic areas; oncology, rare disease, or immunology experience preferred but not mandatory.

• Excellent comprehension of ICH-GCP, FDA, EMA, and other global regulatory guidelines.

• Strong attention to detail, analytical problem-solving abilities, and capacity to manage multiple projects concurrently.

• Effective communication skills and experience collaborating in matrixed research environments.

🏝️ Benefits

• 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 a comparable healthcare background; advanced degree preferred.

• 2 years of medical coding experience in clinical research, ideally within CRO, pharmaceutical, or biotech settings.

• Experience in supporting multiple therapeutic areas; oncology, rare disease, or immunology experience preferred but not mandatory.

• Excellent comprehension of ICH-GCP, FDA, EMA, and other global regulatory guidelines.

• Strong attention to detail, analytical problem-solving abilities, and capacity to manage multiple projects concurrently.

• Effective communication skills and experience collaborating in matrixed research environments.