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: Clinical Coding Specialist

Location: Mumbai, India
Job ID: REQ-10038989
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 Clinical Coding Specialist is responsible for providing consistent and accurate coding for clinical trial data, ensuring that all coding-related documents are up-to-date and meet project timelines. The role involves managing dictionary versions, reviewing glossaries, and troubleshooting coding-related issues. The Specialist is responsible for ensuring that the coding process meets high standards of quality, accuracy, and consistency.

Key Responsibilities:

Clinical Coding Leadership:
- Act as the Lead Coder for multiple trials and programs, ensuring coding is accurate and consistent.
- Apply standard coding conventions and create synonyms as needed, ensuring compliance with project timelines.
Data Management Documentation:
- Maintain coding sections of Data Management Documents and keep dictionary versions up to date.
- Ensure timely updates and completeness of coding data to meet project deliverables.
Trial Support & Timeliness:
- Ensure that coding is completed and reviewed within the established timelines for each trial.
- Support other team members by managing conflicting timelines and coding assignments.
Study Leadership:
- Lead coding activities from study start-up to Database Lock, ensuring the integrity and consistency of coding throughout.
- Provide feedback on coding activities to ensure quality and consistency across the project.
Troubleshooting & Issue Resolution:
- Troubleshoot coding issues, collaborating with database developers, IT support, and other stakeholders to resolve problems efficiently.
- Act as a liaison to resolve coding-related queries and issues with relevant stakeholders.
Dictionary Updates & Synonym Reconciliation:
- Ensure that dictionary upgrades are completed on time and do not impact trial timelines.
- Contribute to synonym reconciliation efforts to maintain data quality.
Contribute to Non-Clinical Initiatives:
- Suggest or contribute to initiatives for dictionary maintenance, process improvements, and system updates.
- Participate in change management, quality improvements, and productivity initiatives as needed.

Key Performance Indicators:

Achievement of overall goals set by the department.
Accuracy and quality of coded data provided for clinical trials.
Timely resolution of coding-related issues and effective communication with the team and stakeholders.
Contribution to non-clinical initiatives that enhance dictionary maintenance and process improvement.

Minimum Requirements:

Work Experience:
- 3+ years of experience in drug development, with at least 2 years of clinical coding experience.
- Strong understanding of medical terminology, including medical conditions and medications.
Skills:
- High attention to detail and accuracy in coding.
- Strong communication, problem-solving, negotiation, and conflict-resolution skills.
- Ability to work independently and manage pressure in a flexible environment.
- Understanding of clinical trial methodology, GCP, and clinical coding tools.
Languages:
- Proficiency in English.

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Clinical Coding Specialist

Job Description

Job Title: Clinical Coding Specialist

Job Summary:

Key Responsibilities:

Key Performance Indicators:

Minimum Requirements:

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