Medical Coding Manager

Summary

Join Cytokinetics as a Coding Manager in Clinical Trials and play a key role in leading and supporting medical coding initiatives across multiple drug development programs. You will oversee coding using standard dictionaries, ensure regulatory compliance, manage workflows, and develop standardized procedures. A key aspect involves developing and maintaining synonym lists for data standardization. Leveraging your expertise in clinical data management and coding technologies, you will enhance coding accuracy and optimize trial efficiency. You will collaborate with internal teams and external partners. This role requires a strong background in medical coding within clinical trials and experience leading coding teams.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Health Informatics, Computer Science, or a related field
• 8+ years of experience in medical coding within clinical trials, pharmaceuticals, or CROs
• 3+ years of experience in leading and managing coding teams
• Expertise in MedDRA and WHO Drug Dictionaries
• Experience with clinical trial databases and EDC/CDM systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC)
• Expertise with coding reconciliation, up versioning query management, and regulatory reporting
• Strong project management and organizational skills
• Excellent written and verbal communication skills
• Ability to train and mentor coding teams
• Strong problem-solving and analytical abilities to ensure high-quality coding data

Responsibilities

• Oversee the coding of adverse events, concomitant medications, and medical history using MedDRA and WHO Drug Dictionary
• Ensure consistency, accuracy, and compliance with regulatory standards in clinical trial coding
• Manage coding workflows, reconciliation processes, and query resolution
• Support coding requirements for regulatory submissions and audits
• Oversee external vendors, CROs, and coding service providers
• Collaborate with cross-functional teams, including CDM, Biostatistics, Regulatory, and Clinical Operations
• Identify and resolve coding discrepancies to maintain data integrity
• Work with clinical teams to ensure proper classification and interpretation of coded terms
• Ensure compliance with ICH-GCP, FDA, EMA, and other global regulatory guidelines
• Develop and maintain synonym lists to ensure consistency in coded terms across studies and databases
• Collaborate with clinical teams to define coding conventions and harmonize terminology across studies
• Ensure proper integration of synonym lists within clinical data management systems
• Assist with additional clinical data management tasks as required

Preferred Qualifications

• Proficiency in SQL, SAS, R, or Python for coding-related data handling and reporting
• MedDRA Coding Certification
• Experience in clinical data management