Senior Clinical Coding Specialist

-Provide timely & professional ongoing Mgmt of Data Mgmt/Coding/CDDRA-Database Development/DAP deliverables and of clinical trial data with respect tProvide 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.
Provide Functional/technical Coding leadership for multiple trials or programs.
Leads and coordinates dictionary administration activities such as synonym review and reconciliation and oversee dictionary version upgrade activities at the portfolio level.

• Provide Clinical Coding leadership for the trials in Multiple Programs/ Therapeutic Area 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.
• Contribute 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 the stakeholders.
• Act 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
• Serve as an SME for Coding, Review & update the Coding documents, Conventions, Training Materials, FRMs, Templates, etc.

• 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

• 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 tool

• Clinical Data Management.
• Data Governance.
• Data Integrity.
• Data Management.
• Data Quality.
• Data Science.
• Databases.
• Project Management.

• English.

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