Remote Clinical Data Code, Oncology

Marlborough, Massachusetts, United States

Remote Clinical Data Code, Oncology needs 2+ years of experience in clinical data coding, preferably in oncology trials.

Clinical Data Code, Oncology requires:

• 20 hours weekly
• Bachelors degree in Life Sciences, Health Information Management, or related field.
• 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.

Clinical Data Code, Oncology duties:

• 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 SMPA 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