Indero is hiring for a Clinical Data Coder for a permanent, full-time, home-based position in India. The role supports clinical data coding and clinical data management activities for ongoing clinical studies, with a focus on accurate and compliant coding using medical dictionaries such as MedDRA and WHO Drug.

The Clinical Data Coder will work across multiple studies, coordinate coding activities, support data review, and ensure coding activities meet applicable regulatory requirements, industry guidelines, Indero SOPs, sponsor requirements, and timelines.

Job Details

Position: Clinical Data Coder

The Clinical Data Coder is responsible for coding clinical data for ongoing clinical studies and supporting clinical data management activities to ensure collected data are managed and reported clearly, accurately, and securely.

The position involves working with MedDRA, WHO Drug/WHODD, coding conventions, coding setups, data review, query management, and clinical database-related activities.

Responsibilities

• Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions.
• Oversee the setup of coding modules for assigned studies.
• Define, document, and manage coding conventions and synonym lists.
• Ensure consistent application of coding conventions across studies.
• Validate sponsor coding licenses.
• Act as Lead Coder and coordinate coding activities across multiple studies.
• Manage coding priorities and 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.
• Support programming of coding reports and related database checks.
• Support data review activities.
• Resolve data clarifications in a timely manner.
• Communicate effectively with Data Management Leads, CRAs, and other stakeholders.
• Perform activities in accordance with applicable regulatory requirements, industry guidelines, Indero SOPs, sponsor requirements, and timelines.

Eligibility & Qualifications

Candidates should have:

• A Bachelor’s degree or educational equivalence in Pharmacy, Life Sciences, or a related field.
• Medical or Nursing qualification with 2 years of relevant experience, or an equivalent combination of education, training, and experience.
• Thorough knowledge of medical terminology and medical dictionaries used for coding, including MedDRA and WHODD.
• Experience working with clinical trials or within the pharmaceutical environment is preferred.
• Understanding and experience with the query management process.
• Knowledge of Good Clinical Practice (GCP).
• Knowledge of applicable Health Canada and FDA regulations/guidelines.

Required Skills

• Clinical data coding
• Medical terminology
• MedDRA and WHO Drug/WHODD
• Coding conventions and synonym lists
• Query management
• Clinical data review
• Coding module setup and validation
• Database checks and coding reports
• Workload and time management
• Organizational and analytical skills
• Attention to detail
• Written and verbal English communication
• Ability to work in a global team environment
• Ability to manage multiple projects simultaneously

Work Location & Application Details

This is a home-based position in India. Attendance at some meetings outside regular business hours, primarily in the evening, is required.

Indero accepts applicants who can legally work in India.

The position offers a flexible work schedule, permanent full-time employment, and ongoing learning and development.

HOW TO APPLY

Application Link