Contract - Medical Coding Manager

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.

We view our employees as the unequivocal ingredients to success. Every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While the expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health and lives of people with cardiovascular and neuromuscular diseases of impaired muscle function.  

As the Coding Manager in Clinical Trials, you will play a key role in leading and/or supporting medical coding initiatives across multiple drug development programs. Your responsibilities will include overseeing the coding using standard dictionaries such as MedDRA and WHO Drug. You will ensure consistency, accuracy, and compliance with regulatory standards while managing coding workflows, reconciliation processes, and the development of standardized coding procedures. Additionally, you will support the evaluation and implementation of coding tools and systems, collaborating with internal teams and CRO partners.

A key aspect of your role will be the development and maintenance of synonym lists, ensuring consistency in coded terms across studies, databases, and regulatory submissions. You will establish processes for updating and harmonizing synonym lists, working closely with clinical data teams to enhance data standardization and streamline coding practices. You will also be supporting Clinical Data Management activities as needed.

Leveraging your in-depth knowledge of clinical data management platforms, coding technologies, and industry best practices, you will drive initiatives to enhance coding accuracy and optimize trial efficiency. You will play a key role in developing, refining, and implementing coding processes to improve quality, streamline operations, and ensure compliance with industry regulations. Your contributions will span all aspects of coding strategies, ensuring data integrity, consistency, and seamless integration within clinical trial databases.

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.

Qualifications 

• 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

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company. 

Please visit our website at: www.cytokinetics.com 

Cytokinetics is an Equal Opportunity Employer 

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications
• We will never request personal information such as banking details until after an official offer has been accepted and verified
• We will never request that you purchase equipment or other items when interviewing or hiring
• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer