Coding Manager in Clinical Trials - Remote

Overview

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

In Short

• 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.

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

Benefits

• Contributions are recognized and rewarded.
• Opportunity to improve lives through innovative medicines.
• Work in a pioneering, values-driven, sustainable biopharmaceutical company.