Senior Clinical Data Coder (India)

• 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.
• Manage coding priorities, balancing workload across timelines and studies.
• Develop and maintain coding guidelines and synonym lists.
• 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.
  

• 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.
  

The work environment

• Flexible work schedule
• Permanent full-time position
• Company benefits package
• Ongoing learning and development
  

About Indero

Indero only accepts applicants who can legally work in India.