|Location:|| Woodcliff Lake 07675, NJ, US
Under the guidance of the Senior Director, Coding & Medical Data Science within the Oncology Business Group (OBG), the Medical Coding Manager performs review of selected codes assigned by first pass coders using MedDRA and WHO-Drug Dictionaries (WHODD). This role is responsible for ensuring accuracy and consistency of coded data within and across protocols and ensures that medical coding deliverables follow regulatory authority requirements at the global platform. This role will also code terms if the first pass coders are having difficulty.
Responsibilities include but are not limited to perform medical coding activities from CRF review of codable pages to coding approval by the Clinical Study Director at Database lock.
Supports the Coding guidelines to ensure this is consistent with the MSSO and UMC guidelines and across OBG processes. Contributes to the synonym-lists to ensure accuracy and consistency of the coded data. Applies GCP principles to ensure all medical coding activities follow SOPs, SWPs and associated guidelines. Participates in SAE coding reconciliation.
Collaborates with colleagues within the study teams across therapeutic areas on coding-related matter especially System –related issues or SAE reconciliation. Consults with Study Directors to resolve medical coding issues/querie, if necessary. Interface with Data Operations during study build coding set up, dictionary migration and resolution on systems issue.
Responsibility includes ability to generate search 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.
The Medical Coding Manager may also be responsible for training, advising and providing direction for Medical Coding contractors.
• Ensures completion of medical coding activities from CRF review of codable pages to coding review and final sign-off of coding approval form by the Clinical Study Director.
• Performs detailed review of selected codes assigned by first pass coder using MedDRA and WHODD any other company dictionary
• Posts coding query and generates coding listings for review to Study Directors
• Generates 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
• Contributes to Oncology coding convention, dictionary upversioning and synonym list
• Coordinates with Data Operations in Study Startup of coding in clinical database and Coding set –up in Coding Environment. Identify and coordinates technical issues regarding coding
• Participates in the development and implementation of department standards and documents as needed
• Bachelor’s degree in relevant biological science or healthcare field
• Minimum of 5 years of experience as a Medical Coder.
• Minimum of 5 years of experience using MedDRA, WHODD, I/J Review, Inform, ds-Navigator, Excel, and Central Coding or other coding tools.
• Requires 4 years of experience supporting Oncology studies and reviewing codeable Case Report Forms; managing CRO global team and supporting Oncology studies; using technical skills such as dictionary manager and setting algorithms (which may have been obtained concurrently).
• Experience handling end to end clinical trials independently.