Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Medical Coding MedDRA Clinical Data Interchange Standards Consortium Clinical Practices FDA Regulations Organizational Structure

Other Skills

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Detail Oriented
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Time Management
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Communication
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Social Skills
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Collaboration

Roles & Responsibilities

2+ years of experience in clinical data coding, preferably in oncology trials
Bachelor's degree in Life Sciences, Health Information Management, or related field
Strong understanding of clinical trial data standards and regulatory requirements
Proficiency with Rave Coder and familiarity with MedDRA and WHO Drug dictionaries

Requirements:

Perform ongoing medical and medication coding using Rave Coder
Review and resolve auto-coded and manually coded terms
Collaborate with Clinical Data Managers to clarify ambiguous terms
Maintain coding listings and ensure all terms are coded and approved prior to database lock

Global Channel Management, Inc.

Human Resources, Staffing & Recruiting

About Global Channel Management, Inc.

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Our account managers will assist in managing fluctuating skill needs, gaps and changing staffing needs to meet a company's need and timelines. GCM is also a hardware and software company that works hard to align companies and individuals with the right products or services to meet their needs.

Company type: TPE

Industry: Human Resources, Staffing & Recruiting

Founded: 2018

Company size: 11 - 50

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Job description

Remote Clinical Data Code, Oncology needs 2+ years of experience in clinical data coding, preferably in oncology trials.

Clinical Data Code, Oncology requires:

Part time
20 hours weekly
Bachelors degree in Life Sciences, Health Information Management, or related field.
Strong understanding of clinical trial data standards and regulatory requirements.
Excellent attention to detail and ability to manage multiple coding tasks in a fast-paced environment.
Results-driven, take initiative and ownership to accomplish work. Knowledge of ICH, Good Clinical Practice and FDA regulations.
Proficiency with Rave Coder and familiarity with MedDRA and WHO Drug dictionaries. Effective time management and organization skills.
Strong communication skills for cross-functional collaboration with CRAs, CDMs, and medical reviewers.
Experience with coding in global, multi-site oncology studies. Good interpersonal, written and verbal communication skills.

Clinical Data Code, Oncology duties:

Perform ongoing medical and medication coding using Rave Coder in accordance with MedDRA and WHO Drug dictionaries.
Review and resolve auto-coded and manually coded terms, ensuring alignment with SMPA coding conventions and internal SOPs
Collaborate with Clinical Data Managers to clarify ambiguous or unclear verbatim terms and issue coding queries when necessary
Maintain coding listings and ensure all terms are coded and approved prior to database lock
Support coding-related documentation and contribute to the development and maintenance of coding guidelines and SOPs
Participate in system validation, user acceptance testing, and updates related to coding modules and dictionary integrations.
Review and resolve complex or ambiguous verbatim terms, escalating to medical reviewers or clinical teams as needed.
Monitor coding metrics and quality indicators, proactively identifying trends and areas for improvement.
Ensure adherence to Data Management standards