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Under the guidance of the Head of Clinical Safety Data Review – Oncology Business Group, performs selection of appropriate codes using MedDRA and WHO-Drug Dictionaries as well as review of coded items across the study and across therapeutic areas. Ensures accuracy and consistency of coded data within and across protocols and ensures that medical coding deliverables follow regulatory authorities requirements at the global platform.
Responsibilities include but not limited to perform medical coding activities from CRF review of codable pages to system coding approval and final sign off of a Clinical Study. Manages the synonym-lists to ensure accuracy and consistency of the coded data, and adherence to regulatory authorities' requirements. Applies GCP principles to ensure all medical coding activities follow SOPs, SWPs and associated guidelines. Participates in SAE coding reconciliation.
Collaborates with colleagues from study teams across therapeutic areas on coding-related matter. Consults with Study Directors to resolve medical coding issues/queries. Interface with Data Operations during study build coding set up, dictionary migration and resolution on systems issue.
Mentors and/or supervises Medical Coders and provides training relevant to Medical Coding function
Responsibility includes generating groupings of similar terms for Adverse Events of Interest or medication of interest.
Interacts with Clinical Safety Data Review group in Review of AESI and take on quality check of clinical summaries if needed.
1. Perform medical coding activities from CRF review of codable pages to system coding approval and final sign off of a Clinical Study and manages the synonym-lists to ensure accuracy and consistency of the coded data.
2. Manage and review coding listings using MedDRA and WHODD or any other company dictionary ;
3. Performs approval of terms, oversees coding query and coding listings for review to study directors
4. Manage requests for grouping of terms for Adverse Events of Interest or Medications of Interest and Interacts with Clinical Safety Data Review team in review of the AESI data
5. Provide Coding guidance to data management in reconciliation of adverse event between clinical and pharmacovigilance database
6. Manages Oncology coding convention, dictionary upversioning and and synonym list
7. Coordinates with Data Operations in Study Start up of coding in clinical database and Coding set –up in Coding Environment. Identify and coordinates technical issues regarding coding
8. Participate in the development and implementation of department standards and documents as needed
A Bachelor's degree in Nursing, Pharmacy or other Biological Science is required.
A minimum of 6 years pharma industry experience
In-depth knowledge of MedDRA and WHO-Drug Dictionaries
Knowledge of Clintrial, Inform, ds-Navigator, Central Coding, any other data management databases/eDC systems and coding applications
Ability to work in a team environment with minimal supervision
Excellent oral and written communication skills
Clinical Data Management experience is a plus
Experience in managing CRO, global team
Experience in supporting Oncology studies
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