Medical Coder

DaMar Staffing; Frederick (MD); On-site; USD 80,000 - 110,000; Full time

Job summary

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 accuracy and regulatory compliance.

The role requires expertise with MedDRA and WHO Drug dictionaries and experience supporting FDA-regulated studies. Collaboration with data review teams and contribution to regulatory submissions are key aspects of the position.

Qualifications

• Bachelor's degree in Health Sciences, Clinical Research, Nursing, Pharmacy, or 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.

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.

Skills

FDA-regulated experience

CDISC knowledge

Attention to detail

Clinical coding

Education

Bachelor's degree in Health Sciences

Tools

MedDRA dictionary

WHO Drug dictionary

Job description

Medical Coder

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.

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 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.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.