Job Description

Job Overview
We are seeking a detail-oriented and technically proficient Clinical Data Coder to support the accurate and timely coding of medical and medication terms within our electronic data capture (EDC) systems, primarily Rave Coder. This role is critical to ensuring data integrity and regulatory compliance across oncology clinical trials.

Job Duties and Responsibilities
•Perform ongoing medical and medication coding using Rave Coder in accordance with MedDRA and WHO Drug dictionaries.
•Review and resolve auto-coded and manually coded terms, ensuring alignment with the companies coding conventions and internal SOPs 
•Collaborate with Clinical Data Managers to clarify ambiguous or unclear verbatim terms and issue coding queries when necessary 
•Maintain coding listings and ensure all terms are coded and approved prior to database lock 
•Support coding-related documentation and contribute to the development and maintenance of coding guidelines and SOPs 
•Participate in system validation, user acceptance testing, and updates related to coding modules and dictionary integrations.
•Review and resolve complex or ambiguous verbatim terms, escalating to medical reviewers or clinical teams as needed.
•Monitor coding metrics and quality indicators, proactively identifying trends and areas for improvement.
•Ensure adherence to Data Management standards.
•Perform other duties as assigned.

Key Core Competencies
•Strong understanding of clinical trial data standards and regulatory requirements.
•Excellent attention to detail and ability to manage multiple coding tasks in a fast-paced environment.
•Results-driven, take initiative and ownership to accomplish work.
•Knowledge of ICH, Good Clinical Practice and FDA regulations.
•Proficiency with Rave Coder and familiarity with MedDRA and WHO Drug dictionaries.
•Effective time management and organization skills.
•Strong communication skills for cross-functional collaboration with CRAs, CDMs, and medical reviewers.
•Experience with coding in global, multi-site oncology studies.
• Good interpersonal, written and verbal communication skills.

Education and Experience
•Bachelor’s degree in Life Sciences, Health Information Management, or related field.
•2+ years of experience in clinical data coding, preferably in oncology trials.
•Ability to work on a computer for extended periods of time.
•Regularly required to sit for long periods of time and occasionally stand and walk.
•Regularly required to use hands to operate computer and other office equipment.
•Close vision required for computer usage.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Pay ranges between $60-66/hr based on experience 

Job Tags

Remote job, Contract work, Work at office,

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