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.
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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.
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