What is your mission? 

You will provide the best service to our partner brands by performing these tasks:

Coding Medical Terminology

• Experience using MedDRA and WHODrug to code adverse events, medical histories, and medications.
• Assign standardized medical codes to adverse events, diagnoses, and procedures.
• Ensure consistency and accuracy in the application of coding rules across clinical trials.

Data Quality Assurance

• Conduct quality control checks on coded data and ensure consistency with source documentation.
• Resolve coding discrepancies and participate in data review meetings to address any coding-related queries.

Collaboration and Communication

• Work collaboratively with clinical data managers and clinical research associates (CRAs) to ensure timely and accurate coding.
• Communicate with study teams regarding the status of coding and any issues that may arise.

Maintenance of Coding Dictionaries

• Maintain and update coding dictionaries to reflect the latest standards and regulatory guidelines.
• Implement updates and changes to coding dictionaries across ongoing studies as needed.

Documentation and Reporting

• Document coding decisions and maintain a log of coding queries and resolutions.
• Generate coding reports and summaries for project teams and regulatory submissions.

Training and Compliance

• Stay current with the latest developments in medical coding standards and regulatory guidelines.
• Provide training or guidance to study teams on coding practices and regulatory requirements as necessary.

Data Review and Quality Checks

• Understand and comply with study protocols: Effectively utilize available resources; Use appropriate methods for quality survey conduct and quality assurance measures for accurate data collection and entry.
• Accurately track current timepoints to ensure timely completion of study objectives.
• Adhere to protocols for internal audits on data completeness, validity, and accuracy.
• Perform data validation checks monitoring for missing data as well as data entry discrepancies.
• Perform validation and user functionality checks on newly created forms prior to those forms going live in a database.
• Perform UAT on new registries and platforms prior to those going live in the database.
• Input tester data to enable project validation.

Who are we looking for?

• At least 1-2 years of experience in medical and drug coding.
• Clinical trial data management experience.
• Knowledge of PHI security (HIPAA).
• Familiarity with MedDRA and WHODrug coding systems.
• Strong knowledge of medical terminology, pharmacology, and clinical trial processes.
• Attention to detail and high accuracy in coding.
• Familiarity with data management systems and EDC platforms.
• Available to start ASAP.