Clinical Coder

Summary

Join RQM+, a leading MedTech solutions partner, as a Clinical Coder and play a crucial role in ensuring the accuracy and completeness of clinical trial data. You will be responsible for assigning appropriate codes to clinical trial data, maintaining detailed records, and collaborating with other teams to ensure smooth data analysis and reporting. This role requires expertise in coding tools and processes, knowledge of regulatory standards and guidelines, and strong attention to detail. You will also be involved in quality assurance activities, participate in user acceptance testing, and stay up-to-date on coding regulations and industry best practices.

Requirements

• Familiarity with clinical trial protocols and medical terminology
• Knowledge of dictionaries, up-versioning dictionaries, coding processes and coding tools
• Technical knowledge in coding tool set-up and implementation process
• Knowledge of safety management and event reporting activities
• Knowledge of data management activities and depending on coding deliverables, the database lock process
• Strong attention to detail and analytical skills
• Excellent teamwork and communication abilities
• Knowledge of applicable clinical research regulatory requirements, i.e., Clinical Trial Regulation, Good Clinical Practice (ICH-GCP) guidelines and international standards like ISO 14155. MedTech regulations and active experience preferred
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required
• Written and verbal communication skills including command of English language
• Organizational and pragmatic problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff and sites

Responsibilities

• Acts as Subject Matter Expert (SME) for coding tools and processes
• Reviews clinical trial data to ensure completeness and accuracy to facilitate data analysis and reporting
• Assigns appropriate codes to clinical trial data to comply with regulatory standards and guidelines
• Maintains detailed records of coded data for regulatory compliance and audit purposes
• Liaises with data management, programming and safety for all processes involving coding
• Participates in User Acceptance Testing for database builds
• Stays up to date on coding regulations/dictionaries and industry best practices
• Performs Quality Assurance activities such as conducting regular audits of coded data to identify and correct errors
• Attends study-related, company, departmental, and external meetings, as required
• Ensures internal and study-related trainings are completed per RQM+ process and/or study timelines, including updating the study level trial management system
• Ensures all study deliverables are completed per RQM+ and study timelines
• Performs other duties, as requested

Benefits

• Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development
• Providing a rewarding place to work is rooted deep in our core values
• From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals
• At RQM+, you are not just another employee, you are a member of RQM+ family