Venesco LLC is seeking a Medical Coder to perform clinical coding activities for adverse events, medical histories, procedures, and concomitant medications for FDA-regulated clinical trials, ensuring consistency, accuracy, and regulatory compliance.
The role supports coding operations, data review, reconciliation, quality control, database testing, validation, training, documentation, and regulatory submission activities.
Requirements & Qualifications
Duties and Responsibilities
- Code adverse events using MedDRA terminology.
- Code medications using WHO Drug Dictionary.
- Develop coding conventions and coding guidelines.
- Review CRFs and contribute to data review activities.
- Perform coding reconciliation activities.
- Generate coding reports and quality control reviews.
- Support database testing and validation activities.
- Conduct coding-related training for study personnel.
- Maintain coding documentation and audit trails.
- Support regulatory submissions and database lock activities.
Minimum Qualifications
- Bachelor's degree in Health Sciences, Clinical Research, Nursing, Pharmacy, or a related discipline.
- MedDRA Certified and WHO-Drug Certified.
- Minimum 7 years of medical coding experience.
- Expertise with MedDRA and WHO Drug dictionaries.
- Experience supporting FDA-regulated clinical studies.
- Knowledge of CDISC and clinical data standards preferred.
Location
Maryland, US
Employment Type
Full-time
Experience Level
Senior
Salary Range
$85,000 - $105,000
Remote work allowed
No
Posted
4 weeks ago
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