Senior Medical Coder

Education & Experience

• Bachelors degree in life sciences, nursing, pharmacy, public health, or equivalent healthcare background; advanced degree preferred.

• 5-8+ years of medical coding experience in clinical research

• MedDRA and WHODrug

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

Technical & Professional Skills

• Proficient in clinical data management systems (e.g., Medidata Rave, Oracle Inform, Veeva, or similar).

• 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.

Medical Coding

• 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 or data management for clarification.

• Maintain coding conventions and ensure alignment with study-specific and sponsor requirements.

Data Quality & Review

• Conduct ongoing coding checks during data cleaning cycles and prior to database lock.

• Lead the resolution of coding discrepancies, queries, and coding-related data issues.

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

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

Process Leadership & Subject Matter Expertise

• Serve as the primary point of contact for coding questions across studies or therapeutic areas.

• Provide guidance and training to junior medical coders, data management staff, and clinical teams.

• Develop and maintain standard operating procedures (SOPs), work instructions, and coding guidelines.

• 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.

Cross-Functional Collaboration

• 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.