Senior Clinical Coding Specialist
Job ID: REQ-10038991
Date: Apr 02, 2025
Location: India
Summary:
Provide timely & professional ongoing management of Data Management/Coding/CDDRA-Database Development/DAP deliverables and of clinical trial data by performing accurate and consistent coding, providing inputs to the relevant coding sections of the Data Management Documents, and reviewing coding glossaries. Provide Functional/technical Coding leadership for multiple trials or programs. Leads and coordinates dictionary administration activities such as synonym review and reconciliation and oversees dictionary version upgrade activities at the portfolio level.
About the Role:
Major Accountabilities:
Provide Clinical Coding leadership for the trials in Multiple Programs/Therapeutic Areas to ensure that the Coding is performed at a consistently high standard, documents are up to date, dictionary versions are upgraded on time, and glossaries are reviewed to maintain the quality of the Coding for timelines/deliverables.
Specific responsibility of leading synonym review & reconciliation processes and Dictionary version upgrades at portfolio level.
Ensures that coding is completed in support of all timelines/deliverables and supports other members with their assignments.
Contributes to non-clinical initiatives related to dictionary maintenance and update, process improvement initiatives, system update and change management, quality, and productivity improvement, etc.
Troubleshoots coding problems, collaborating with peers, database developers, and IT support as needed.
Effectively represents the Coding in the CTT meetings or in communications with stakeholders.
Acts as a trainer, coach/mentor to the other team members of the team to work as Lead Coder and contribute/drive activities for the non-clinical project.
Serves as an SME for Coding, Reviews & updates the Coding documents, Conventions, Training Materials, FRMs, Templates, etc.
Key Performance Indicators:
Contribute to the achievement of overall goals as set each year by Function.
Quality, completeness, and timeliness of deliverables.
Ability to accurately detect and resolve quality issues/inconsistencies in coded data.
Ability to effectively communicate with CTT members, IT Support team, and others about coding-related processes and issues to support system/process/dictionary updates/improvements and/or efficient issue resolution.
Minimum Requirements:
Work Experience:
4 or more years of experience in drug development with at least 3 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 the 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.
Skills:
Clinical Data Management
Data Governance
Data Integrity
Data Management
Data Quality
Data Science
Databases
Project Management
Languages:
English.
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