JOB DESCRIPTION

JOB RESPONSIBILITIES:

• Adherence to SOPs and maintaining audit-ready documentation.
• Provide for clinical coding support across multiple therapeutic areas.
• Be accountable for the quality, traceability, reproducibility, and timeliness of coding deliverables.
• Develop and maintain coding conventions for a specific protocol or program.
• Perform accurate coding of medical terms and medications utilizing industry-wide standards as well as company standards.
• Review all coded terms for accuracy and consistency and appropriately address coding discrepancies or inconsistencies.
• Issue queries in EDC to ensure high quality coding.
• Produce coding reports from EDC for team review and utilization.
• Perform impact analysis of the up-versioning of MedDRA and WHO Drug dictionaries
• Communicate with internal and external clients.
• Keep abreast of current and new coding techniques and other applicable technical advancements while assisting in their implementation.

QUALIFICATIONS:

Education: Bachelor’s degree in Life Sciences, Computer Science or related discipline.

Experience: 1-2 years of progressive hands-on experience in Clinical Data Management (coding group) or Clinical Research.

Skills:

• Proficiency in at least one of the prevalent coding tools (e.g., Medidata Rave Coder, Merative Zelta Coder etc., ).
• Experience with using MedDRA and WHO Drug dictionaries preferred.
• Experience working with clinical trials or within the pharmaceutical environment is preferred.
• Knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents (SOPs/Guidelines/Work Instructions).
• Knowledge of ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
• Good verbal and written communication.
• Flexibility, proactivity, and ability to work independently and in a team environment.
• Detail-oriented with analytical mind-set.
• Good Problem-solving skills.