2 - 6 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Precision for Medicine is looking for a skilled Medical Coder to provide comprehensive Coding and related data management support during all phases of the clinical trial data management process. Working under direct supervision with a team of medical coders, you will ensure compliance with Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role involves various responsibilities, including data coding, quality review, and collaboration within a dynamic team environment. The Coder will be responsible for providing Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full-time basis. They will follow Standard Operating Procedures/Work Instructions (SOPs/WIs), regulatory directives, and study-specific plans and guidelines. This position involves performing Coding quality reviews and working closely with the Coding Manager to prioritize coding tasks for timely completion. Key responsibilities of the job include but are not limited to: - Conducting medical coding of medical terms to ensure logic and consistency (MedDRA and WHODRUG) - Supporting other team members as needed, ensuring tasks are completed promptly - Performing quality control of Coding - Providing input into Coding timelines for overall deliverables - Meeting clinical data coding deadlines with quality - Reviewing feedback from stakeholders - Conducting coding dictionary upgrade UAT and maintaining quality-controlled documentation - Creating, revising, versioning, and maintaining data management coding documentation - Training clinical research personnel on study-specific Coding related items - Reviewing and querying coding data as per the Data Management Plan and Coding standards - Running coding status and metric reporting - Assisting in the development and maintenance of SOPs and process documentation related to coding activities - Ensuring all team members have received sufficient training - Communicating with study sponsors and project teams as required - Conducting coding demonstrations/trainings and participating in department/company training sessions and project meetings - Performing other assigned duties Requirements: - Minimum of 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - At least 2 years of experience in performing Dictionary medical coding (MedDRA and WHODrug) - Proficiency in Microsoft Office applications - Strong organizational and communication skills - Basic knowledge of drug, device, and/or biologic development and data management practices Preferred Qualifications: - Experience in a clinical, scientific, or healthcare discipline - Oncology and/or Orphan Drug therapeutic experience Skills: - Demonstrated knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance - Ability to implement and drive outcomes Precision Medicine Group ensures that any data provided as part of the application process will be stored in accordance with its Privacy Policy. For CA applicants, please refer to the CA Privacy Notice. Individuals with disabilities requiring accommodations during the application process may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. Please note that the organization follows a formal interview process and communicates directly with candidates before extending a job offer to prevent fraudulent activities by unauthorized individuals or organizations.,

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