| || • Performs accurate/consistent coding, applying standard conventions, creating ap-propriate synonyms, creating/closing coding-related queries, and interacting with TDMs/CTHs/Medics/others as needed
• Leads/manages synonym review and update processes
• Ensures that coding is completed in support of all timelines/deliverables
• Maintains Coding-related section(s) of study DHPs (or equivalent documents)
• Troubleshoots coding problems, collaborating with peers, database developers, and/or IT support as needed
• Effectively represents the Coding Team in dictionary update efforts, process im-provement initiatives, and/or system update efforts
• Serves as a Coding SME
| || • University or college degree in life science, chemistry, pharmacy, nursing, or equivalent relevant degree. Advanced Pharmacy degree preferred.
• English (oral and written)
• 6 or more years of experience in drug development with at least 5 years performing Clinical coding.
• Demonstrated ability to adapt to different coding technologies
• Expert level of knowledge of medical terminology, including medical conditions and medications
• Strong attention to detail.
• Strong verbal and written communication skills, including ability to author Coding conventions, SOPs/WPs, and training materials
• Good problem-solving, negotiation and conflict resolution skills
• Ability to work independently, under pressure, and in an environment where flexibility is required.
• Understanding of clinical trials methodology, GCP, system validation requirements, and coding tools