Senior Medical Coder
The Senior Medical Coder plays a critical role in supporting clinical trials by ensuring the accurate, consistent, and timely coding of medical terms using standardized dictionaries (e.g., MedDRA, WHO Drug). This individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Senior Medical Coder serves as a subject matter expert and collaborates cross-functionally with clinical operations, data management, safety/pharmacovigilance, biostatistics, and medical writing teams to maintain high-quality data that meet global regulatory standards.
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.
Education & Experience
- Bachelor's degree in life sciences, nursing, pharmacy, public health, or equivalent healthcare background; advanced degree preferred.
- 58+ 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.
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.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.