Senior Medical Coder
- 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.
- 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.
- 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.
- 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.
- Bachelor's 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 , 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.
- 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.
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