Senior Clinical Data Coder

Posted 1hrs ago

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Job Description

Senior Clinical Data Coder leading medical and medication coding for Indero’s global dermatology and rheumatology clinical trials. Managing coding setups, conventions, priorities, and data review.

Responsibilities:

  • Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions
  • Oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows
  • Define, document, and manage coding conventions and ensure consistent application across studies
  • Act as the Lead Coder, coordinating coding activities across multiple studies simultaneously
  • Validate sponsor coding licenses
  • Manage coding priorities, balancing workload across timelines and studies
  • Provide input to the Coding section of Data Management Plans
  • Oversee and perform dictionary up-versioning and related upgrade activities
  • Validate and test coding setups, programming of coding reports, and related database checks
  • Support data review activities and resolve data clarifications in a timely manner
  • Provide mentorship and guidance to junior or back-up coders
  • Actively contribute to process optimization, SOP development, and best practices in coding
  • Maintain effective communication with Data Management Leads, CRAs, and other stakeholders
  • Attend some meetings outside regular business hours, primarily in the evening

Requirements:

  • Bachelor’s degree or equivalent in pharmacy, life sciences, or a related field (medical/nursing background also acceptable)
  • Minimum of 5 years’ relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO environment
  • Thorough knowledge of medical terminology and medical dictionaries (MedDRA, WHO Drug)
  • Demonstrated experience with coding module setup, management of conventions, and prioritization of tasks across multiple studies
  • Experience in query management and clinical data review
  • Proven ability to manage multiple studies concurrently
  • Excellent written and verbal English communication skills
  • Strong organizational and analytical skills with high attention to detail
  • Ability to lead within a global team environment, providing guidance to colleagues and ensuring deliverables are met
  • Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines
  • Must be legally able to work in India

Benefits:

  • Flexible work schedule
  • Permanent full-time position
  • Ongoing learning and development
  • Attractive advancement opportunities