The Clinical Data Coder is primarily responsible for providing support to activities related to coding of Clinical data for ongoing clinical studies. The Clinical Data Coder will also participate in various clinical data management activities required to ensure that data captured are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.
More specifically, the Clinical Data Coder must:
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, synonym lists and ensure consistent application across studies.
Validate sponsor coding licenses.
Act as the Lead Coder,
coordinating coding activities across multiple studies simultaneously.
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.
Maintain effective communication with Data Management Leads, CRAs, and other stakeholders.
Requirements
Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 2 years relevant experience or equivalent combination of education, training and experience;
Thorough knowledge of Medical Terminology and Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.);
Experience working with clinical
📌 Clinical Data Coder-India (Pune)
🏢 Indero
📍 Pune
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