Clinical Data Specialist
2 weeks ago
ICON plc is a leading provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, medical device and government organisations.
The Medical Coding Specialist performs key activities in coding clinical data according to Clinical Trial Protocol requirements, using established global and therapeutic area coding guidelines and processes. This role involves close collaboration with Data Managers, Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
Key Responsibilities:
- Deliver timely, consistent, accurate and reproducible coding of clinical trial data using industry standard coding dictionaries (MedDRA, WhoDrug) aligned with global and therapeutic area guidelines.
- In collaboration with Global Data Manager, develop trial coding specifications defining coding elements, dictionary versions and review timelines.
- Complete and submit Medidata Project Registration requests.
- Maintain access to coding systems and perform independent quality control of trial data coding.
- Prepare and transmit trial data coding for consistency and accuracy review per trial coding specification.
- Address coding issues or revisions resulting from coding QC or consistency and accuracy review implementing coding reclassifications where required.
- Perform post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.
Requirements:
- Bachelor's degree in Health Sciences or equivalent.
- Minimum 3 years of experience in Clinical Data Coding supporting clinical research.
- In-depth knowledge of industry standard coding thesauri (MedDRA, WHO Drug) and ability to utilise incumbent dictionary encoding products and systems.
- Experience working on clinical trials and in diverse teams within clinical research.
- Working knowledge of GCP/ICH guidelines and excellent written and verbal communication skills in English.
Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma and IT. Estimated salary: $80,000 - $110,000 annually, depending on experience and location.
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