Job description
RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.
Our tailored solutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science, comprehensive clinical trial design and execution, and impactful reimbursement strategies — accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.
We don’t make MedTech. We make MedTech happen.
RQM+ clinical trial services maintains the highest level of integrity and brings unique value to MedTech manufacturers. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency
The Clinical Coder primarily oversees the coding process for applicable clinical trials. Works with the Safety and Data Management teams to review and code terms per the procedures set forth by RQM+ and sponsors. Facilitates review and coding activities to allow other functional processes to proceed smoothly.
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
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.
Behaviors:
- Action-Oriented, Approachability, Business Acumen, Career Ambition, Composure, Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
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. Make your impact today!
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
Job Opportunity Verification
At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:
All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
Every candidate going through the interview process will participate in a voice and/or video interview.
Exercise caution with unsolicited job offers or requests for sensitive information.
