The posting
About Signant Health At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands-on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency.
Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions powered by AI innovation that make clinical trials more efficient, more accurate, and more accessible around the world. Trusted by leading pharmaceutical companies and CROs, our platforms and services support studies across more than 90 countries and have contributed to hundreds of new drug approvals.
If you are motivated by meaningful work, global impact, and innovation in clinical research and digital health — including the opportunity to work with cutting-edge AI technologies — you will find purpose and opportunity at Signant Health.
About the Role The Medical Coder is responsible for working with Clinical Data Management to provide medical coding services for our customers, ensuring on-time and accurate deliverables. Specific responsibilities include coding medical terms using MedDRA/WHODrug and providing related guidance to internal project team members and customers; authoring relevant data management documents; and performing user acceptance testing on data management deliverables.
KEY ACCOUNTABILITIES – Function
Codes medical terms, adverse events (AEs), and concomitant medications using standard dictionaries such as MedDRA and WHODrug across multiple clinical trials. Leads the resolution of complex coding issues and discrepancies. Performs encoder user acceptance testing. Authors relevant sections of the data management plan (DMP). Ensures compliance with regulatory requirements for clinical trial coding (e.g., FDA, EMA). Provides guidance and communicates with internal project team members and customers on all aspects of medical encoding. Facilitates risk assessments for mid-study changes and executes dictionary upversioning. Collaborates with functional groups to address technical issues impacting quality, and drives forward technical initiatives within Data Management. Communicates effectively within a multi-disciplinary project team to complete assigned tasks with high quality, on time, and within budget.
Decision Making and Influence
Contributes to the execution of process improvements.
KNOWLEDGE, SKILLS & ATTRIBUTES Essential:
Bachelor’s degree in a relevant medical field or equivalent work experience. Proficient in MedDRA and WHODrug coding. Demonstrates extreme attention to detail and organization in all aspects of work. Strong verbal and written communication skills. Demonstrated ability to meet very short deadlines and multi-task in an extremely fast-paced work environment with minimal direct supervision. Proven ability to work both independently and in a team-oriented environment, providing back-up support to team members and establishing/maintaining effective working relationships with co-workers within and across functional areas. Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling and process changes that are inherent in a fast-paced business. Proficient in Access, Excel, and other office software technologies and applications. Ability to quickly learn and apply new skills, procedures, and approaches.
Desirable:
2+ years of professional experience in medical coding in the clinical trials data space. Familiarity with 21 CFR Part 11 or experience in a regulated environment is desirable.
