Senior Medical Coder

DaMar Staffing; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

DaMar Staffing is seeking a Medical Coding Specialist to perform dictionary coding using MedDRA and WHODrug within eCRF systems across multiple projects, ensuring accuracy and timeliness.

You will lead and mentor Coding Specialists, create training materials, and liaise with Clinical Data Managers and clients to address coding requests and timelines. Strong knowledge of ICH/GCP and regulatory requirements is essential.

Qualifications

• 5+ years in Pharmaceutical/Biotechnology industry or CRO environment
• Thorough knowledge and experience with WHODrug AND MedDRA dictionaries
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Excellent verbal and written communication skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent team player
• Proficiency in Microsoft Office Applications
• Working knowledge of MedDRA and WHODrug best practice documents
• Good understanding of Clinical Data Management processes and the applicable regulatory requirements
• Good overview of all systems linked to the coding process, and understanding of their interactions and dependencies

Responsibilities

• Perform coding in accordance with study specific coding conventions as outlined in the Data Management Plan (DMP)
• Perform coding using MedDRA and WHO Drug of (eCRF) verbatim terms using various coding systems
• Provide independent review of coded data by ensuring consistent code assignment within a project by reviewing coding and re-assignment
• Responsible for medical coding review, synonym dictionaries review, therapeutically aligned coding conventions
• Create, review, and maintain guidance and training documentation for coding guidelines and dictionary definitions
• Provide support to other departments concerning dictionary use and code assignment
• Ensure compliance with industry quality standards, regulations, guidelines and procedures
• Management of query assignment within eCRF systems for questionable verbatim terms
• Preparation of specific study coding reports for accuracy and consistency as well as client requirements
• Interaction with clients regarding specific coding requests and coding timelines
• Participate in system upgrades, including User Acceptance Testing (UAT) to maintain a validated coding environment
• Perform coding related study close activities ensuring all coding is accurate and proper documentation is complete
• Liaise with Clinical Data Managers and Programmers for purposes of project requirements
• Communicate issues that require decisions, including proposal for a solution
• CTCAE coding and review

Skills

Verbal communication

Written communication

Multitasking

Team player

Organization

Education

Bachelor's degree in biology or health-related field

Tools

MedDRA

WHODrug

eCRF systems

Microsoft Office

Job description

Medical Coding Specialist

Perform dictionary coding in accordance with study specific coding conventions using MedDRA and WHO Drug within various coding systems. Manage end-to-end delivery of clinical data management coding responsibilities concurrently for single/multiple projects ensuring quality and timeliness. Provide leadership and mentorship to Medical Coding Specialists as needed. Create, review, and maintain guidance and training documentation for coding guidelines an accordance with ICH guidance, official coding guidelines and dictionary definitions.

Responsibilities:

• Perform coding in accordance with study specific coding conventions as outlined in the Data Management Plan (DMP)
• Perform coding using MedDRA and WHO Drug of (eCRF) verbatim terms using various coding systems
• Provide independent review of coded data by ensuring consistent code assignment within a project by reviewing coding and re-assignment
• Responsible for medical coding review, synonym dictionaries review, therapeutically aligned coding conventions
• Create, review, and maintain guidance and training documentation for coding guidelines an accordance with ICH guidance, official coding guidelines and dictionary definitions
• Provide support to other departments concerning dictionary use and code assignment
• Ensure compliance with industry quality standards, regulations, guidelines and procedures
• Management of query assignment within eCRF systems for questionable verbatim terms
• Preparation of specific study coding reports for accuracy and consistency as well as client requirements
• Interaction with clients regarding specific coding requests and coding timelines
• Participate in system upgrades, including User Acceptance Testing (UAT) to maintain a validated coding environment
• Perform coding related study close activities ensuring all coding is accurate and proper documentation is complete
• Liaise with Clinical Data Managers and Programmers for purposes of project requirements
• Communicate issues that require decisions, including proposal for a solution
• CTCAE coding and review

Experience:

• 5+ years in Pharmaceutical/Biotechnology industry or CRO environment
• Thorough knowledge and experience with WHODrug AND MedDRA dictionaries
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Excellent verbal and written communication skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent team player
• Proficiency in Microsoft Office Applications
• Working knowledge of MedDRA and WHODrug best practice documents
• Good understanding of Clinical Data Management processes and the applicable regulatory requirements
• Good overview of all systems lined to the coding process, and understanding of their interactions and dependencies

Education:

• Bachelor of Science degree in biology or health-related field preferred

Language Skills Required:

Speaking: English (Required)

Writing/Reading: English (Required)