Clinical Data Coder (Remote, Part-Time)

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 part-time remote role plays a vital part in ensuring data integrity and regulatory compliance across oncology clinical trials.

Job Duties and Responsibilities

• Perform ongoing medical and medication coding using Rave Coder in alignment with MedDRA and WHO Drug dictionaries.
• Review and resolve auto coded and manually coded terms, ensuring adherence to SMPA coding conventions and internal SOPs.
• Collaborate with Clinical Data Managers to clarify ambiguous or unclear verbatim terms and issue coding queries when needed.
• Maintain coding listings and ensure all terms are coded and approved before 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.
• Escalate complex or ambiguous verbatim terms to medical reviewers or clinical teams when necessary.
• Monitor coding metrics and quality indicators, proactively identifying trends and opportunities for process improvements.
• 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; takes initiative and ownership to accomplish tasks effectively.
• Knowledge of ICH, Good Clinical Practice (Google Cloud Platform), and FDA regulations.
• Proficiency with Rave Coder and working knowledge of MedDRA and WHO Drug dictionaries.
• Effective time management and organizational skills.
• Strong communication and interpersonal skills for collaboration with CRAs, CDMs, and medical reviewers.
• Experience in coding for global, multi-site oncology studies.

Education and Experience

• Bachelor s degree in Life Sciences, Health Information Management, or a related field.
• Minimum of 2 years of experience in clinical data coding, preferably in oncology trials.
• Ability to work on a computer for extended periods.
• Must be able to sit for long periods and occasionally stand or walk.
• Regular use of hands for operating computers and office equipment; close vision required.