Senior Clinical Coding Specialist

Novartis

3-4 years

Not Disclosed

India Mumbai

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: India (Mumbai, Office)
Job ID: REQ-10038991
Date Posted: Feb 03, 2025
Division: Development
Business Unit: Innovative Medicines
Employment Type: Full-Time, Regular
Shift Work: No

Job Purpose

The Senior Clinical Coding Specialist provides leadership and oversight in clinical coding for multiple trials or programs across various therapeutic areas. This role ensures accurate, timely, and high-quality coding of clinical trial data and contributes to coding glossary management, synonym review, reconciliation, and dictionary version upgrades at the portfolio level. The specialist acts as a Subject Matter Expert (SME) and provides training, mentorship, and technical leadership to team members.

Key Responsibilities

Clinical Coding Leadership

Lead clinical coding activities for multiple trials, ensuring coding is completed consistently and within timelines/deliverables.
Maintain up-to-date coding documents and ensure timely upgrades of dictionary versions.
Lead synonym review and reconciliation processes, ensuring consistent and accurate data coding.
Represent coding functions in Clinical Trial Team (CTT) meetings and liaise with stakeholders to address coding-related issues.

Dictionary Administration & Maintenance

Oversee and coordinate dictionary administration activities, including synonym review, reconciliation, and version upgrades at the portfolio level.
Contribute to process improvement initiatives related to dictionary maintenance, system updates, and change management.

Training & Mentorship

Act as a trainer and mentor for team members, guiding them to work effectively as lead coders.
Contribute to the creation and update of training materials, coding conventions, and standard operating procedures (SOPs).

Problem-Solving & Issue Resolution

Troubleshoot coding problems and collaborate with peers, database developers, and IT support to resolve issues effectively.
Ensure accurate detection and resolution of coding inconsistencies and quality issues.

Key Performance Indicators

Timely and accurate completion of coding deliverables.
Effective leadership and coordination of coding activities across trials/programs.
High-quality, consistent, and compliant coding processes.
Successful resolution of coding-related issues and efficient system/process improvements.
Contribution to achieving overall functional goals, quality standards, and training objectives.

Minimum Requirements

Work Experience

4+ years of experience in drug development, with at least 3 years focused on clinical coding.
Proven ability to adapt to various coding technologies.
Expertise in medical terminology, including medical conditions and medications.
Strong attention to detail, with excellent problem-solving, negotiation, and conflict-resolution skills.

Skills

Clinical Data Management, Data Governance, and Data Integrity.
Proficiency in clinical trials methodology, GCP, system validation, and coding tools.
Excellent verbal and written communication skills, including creating SOPs, training materials, and coding conventions.
Strong leadership and ability to work independently under pressure.

Languages

Proficiency in English.

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