Senior Medical Coder
Cytel
Summary
The 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, WHODrug). This individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Medical Coder collaborates cross-functionally with clinical operations, data management, safety and risk management, biostatistics, and medical writing teams to maintain high-quality data that meet global regulatory standards.
Job description
Responsibilities
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 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.
- 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.
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.
Qualifications
- 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.
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 equivalent healthcare background
- 2 years of medical coding experience in clinical research
- Excellent understanding of ICH-GCP, FDA, EMA, and other global regulatory guidelines
- Strong attention to detail
- Analytical problem-solving
- Ability to manage multiple projects simultaneously
- Effective communication skills
- Experience collaborating in matrixed research environments
Company overview
Cytel is a global leader in data-science contract research organization (CRO) services, specializing in advanced statistical analytics and innovative clinical trial software solutions. Founded in 1987 and headquartered in Cambridge, Massachusetts, the company has established itself as a pioneer in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. With over 2,000 employees across North America, Europe, and Asia, Cytel provides comprehensive services ranging from innovative trial design to end-to-end biometrics and real-world evidence solutions. The company's mission focuses on accelerating drug development, enhancing success rates, and delivering better patient outcomes through robust analytics and specialized multidisciplinary expertise. Cytel's software products, including the East Horizon platform and StatXact statistical software, are widely used by major biopharmaceutical companies and regulatory agencies worldwide, supporting the design, simulation, and monitoring of adaptive clinical trials.