Clinical Coding Specialist

Clinical Coding Specialist

Job Description Summary

-Provide timely and professional ongoing management 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.
Ensures that Coding is current, accurate, dictionary versions and documents are up to date, and database deliverables/timelines are met from Coding
perspective with utmost quality & consistency of data Coding.

Job Description

Major accountabilities:

• Acts as a Lead Coder for multiple trials/ Programs. Performs accurate and consistent coding by applying standard conventions, creating appropriate synonyms and creating/managing coding-related queries as needed.
• Maintaining the Coding-related section(s) of Data Management Documents as well as keeping the dictionary versions up to date.
• Ensures that coding is completed & reviewed in support of study timelines/deliverables, able to manage conflicting timelines/deliverables, and supports other members with their assignments.
• Independently leads the study from start-up to Database Lock activities from Coding perspective.
• Reviews and provides feedback on coding performed by self or others to ensure consistency and quality.
• Troubleshoots coding problems, collaborating with peers, database developers, and/or IT support as needed.
• Consults and liaise with relevant stakeholders to resolve Coding queries and issues.
• Ensures that dictionary upgrades are completed in a timely manner across remit of trials without impact to the trial timelines/deliverables, contributes in synonym reconciliation.
• May suggest or contribute to non-clinical initiatives related to dictionary maintenance and update, process improvement initiatives, system update and change management, quality, and productivity improvement, etc

Key performance indicators:

• Contribute to the achievement of overall goals as set each year by Function.
• Ability to accurately provide quality coded data
• Ability to effectively communicate with the Supervisor/TDM about coding-related processes and issues to support efficient issue resolution

Minimum Requirements:
Work Experience:

• 3 or more years of experience in drug development with at least 2 years performing Clinical coding.
• Strong understanding of medical terminology, including medical conditions and medications
• Strong attention to detail.
• Good communication, 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 and coding tools.

Languages:

• English.

Skills Desired

Clinical Data Management, Databases, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, Waterfall Model

Experience Level

Senior Level