The Medical Coder will perform coding in both MedDRA and WHODRUG dictionaries for assigned studies, following SOPs, regulatory directives, and study-specific plans. Responsibilities include data coding, quality review, and supporting team members to ensure continuity and timely task completion.
Essential Functions:
- Perform medical coding using MedDRA and WHODRUG dictionaries.
- Support team members as a backup and ensure timely task performance.
- Conduct quality control of coding.
- Provide input on coding timelines for overall deliverables.
- Ensure clinical data coding deadlines are met with high quality.
- Assess resource needs for assigned projects as needed.
- Review and provide feedback from all stakeholders.
- Conduct coding dictionary upgrade UAT and maintain quality-controlled documentation.
- Create, revise, and maintain data management coding documentation.
- Train clinical research personnel on study-specific coding items.
- Review and query coding data according to the Data Management Plan and coding standards.
- Run coding status and metric reporting.
- Participate in the development and maintenance of SOPs and corresponding process documentation related to coding activities.
- Communicate with study sponsors and project teams regarding coding.
- Present coding demonstrations/trainings and participate in department/company training sessions and project meetings.
- Perform other duties as assigned.
Qualifications:
Minimum Required:
- 4+ years’ experience within Data Management.
- Bachelor’s degree in a scientific/science background or a combination of related experience.
- 2+ years performing dictionary medical coding (MedDRA and WHODrug).
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Excellent organizational and communication skills.
- Professional proficiency in English, both written and oral.
- Basic knowledge of drug, device, and/or biologic development and effective data management practices.
Preferred:
- Experience in a clinical, scientific, or healthcare discipline.
- Experience in oncology and/or orphan drug therapeutic areas.
- Strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance with the ability to implement and drive outcomes.
Skills:
- Strong knowledge of ICH-GCP and relevant SOPs.
- Ability to handle a variety of data management tasks and oversight.
- Demonstrates excellent organizational and communication skills.
