Instagram
youtube
Facebook

Clinical Coding Specialist

3-4 years
Not Disclosed
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.