Senior Clinical Coding Specialist

Novartis

4-5 years

Not Disclosed

Hyderabad India

10 Feb. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Coding Specialist

Location: Hyderabad, India
Job ID: REQ-10038990
Date Posted: Feb 03, 2025
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular
Shift Work: No

Job Summary:

The Senior Clinical Coding Specialist is responsible for providing leadership in clinical coding for multiple trials and programs. This role requires accurate and consistent coding of clinical trial data, overseeing dictionary administration activities, and ensuring that all coding deliverables meet timelines, quality standards, and compliance. The Senior Specialist also supports process improvement initiatives and serves as a subject matter expert (SME) for clinical coding activities.

Key Responsibilities:

Clinical Coding Leadership:
- Provide functional and technical leadership in coding for multiple trials/programs within a therapeutic area.
- Ensure high-quality coding is performed and documents are updated consistently, including dictionary version upgrades and glossary reviews.
Dictionary Management and Reconciliation:
- Lead synonym review and reconciliation processes across multiple trials.
- Oversee timely dictionary version upgrades, ensuring they align with project timelines and deliverables.
Support Trial Timelines:
- Ensure timely completion of coding for all assigned trials, supporting project timelines and deliverables.
- Assist and support other team members with their coding assignments as necessary.
Contribute to Non-Clinical Initiatives:
- Contribute to process improvements, system updates, and change management initiatives.
- Enhance quality and productivity through continuous improvements in coding practices.
Troubleshooting and Issue Resolution:
- Troubleshoot coding-related issues and collaborate with database developers and IT support to resolve them efficiently.
- Act as a point of contact for coding-related queries in Clinical Trial Team (CTT) meetings and other communications.
Mentorship and Training:
- Serve as a mentor and trainer for junior team members, helping them develop their skills in clinical coding.
- Update and review coding documents, conventions, training materials, and templates.

Key Performance Indicators:

Achievement of function-specific goals as set each year.
Quality, completeness, and timeliness of coding deliverables.
Ability to detect and resolve quality issues and inconsistencies in coded data.
Effective communication with CTT members, IT support, and stakeholders regarding coding processes, improvements, and issue resolution.

Minimum Requirements:

Work Experience:
- 4+ years of experience in drug development, with at least 3 years performing clinical coding.
- Proven experience in adapting to various coding technologies and tools.
- Expert knowledge of medical terminology, including medical conditions and medications.
Skills:
- Strong attention to detail and accuracy in coding.
- Strong verbal and written communication skills, including the ability to create coding conventions, SOPs, training materials, and more.
- Problem-solving, negotiation, and conflict resolution skills.
- Ability to work independently and under pressure in a flexible environment.
- Strong understanding of clinical trial methodology, GCP, system validation, and coding tools.
Languages:
- Proficiency in English.

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