Sr. Medical Coding Specialist Project Consultant - Artech LLC

Job Title: Sr. Medical Coding Specialist – Project Consultant – 100% Remote
Location: Fully Remote
Duration: 12+ Months (with potential extension)

Shift Schedule: Monday – Friday, 8:00 AM – 5:00 PM

Job Description
We are seeking a highly skilled Sr. Medical Coding Specialist – Project Consultant to join our dynamic team. The ideal candidate will possess a strong background in medical coding within a pharmaceutical or clinical research setting and be proficient in using industry-standard coding systems.

Key Responsibilities:

• Coding Oversight: Lead and oversee all medical coding activities for assigned clinical studies, ensuring accurate and consistent coding of medical terminology using MedDRA and WHODrug according to company conventions and regulatory requirements.
• Coding Lead: Serve as the coding lead for active clinical trials, including the creation of the Medical Coding Plan (MCP) at study startup. Collaborate with the Clinical Study Physician (CSP) and other stakeholders to ensure timely coding deliverables.
• Quality Control: Conduct Quality Control (QC) reviews of coding performed by outsourced service providers, identifying discrepancies and requesting data clarifications as necessary.
• Collaboration: Foster positive partnerships with CROs, providing feedback and guidance to ensure a high standard of deliverables. Actively participate in study team meetings, interacting with multifunctional areas to ensure accurate data capture.
• Database Maintenance: Assist in maintaining coding databases, including version upgrades and enhancements of coding algorithms and synonym tables.
• Documentation: Ensure all coding is complete and without discrepancies prior to database clean/lock activities, with all documentation stored in relevant folders.
• Compliance: Adhere to Safety, Health, and Environmental policies and procedures while performing other tasks and projects as assigned.

Qualifications:

• Education: RN with a Bachelor's degree or higher (PharmD also considered). Candidates with lesser education may qualify if their experience and demonstrated skills are commensurate.
• Experience: Minimum of 5 years of medical coding experience in a pharmaceutical or clinical research setting. Recent experience with MedDRA and WHODrug coding, including ATC coding based on indication and route, is required.
• Technical Skills: Proficiency in Medidata Rave Coder and Veeva Vault Coder, with the ability to code using these tools. Experience with MedDRA, WHODrug, MSSO MedDRA Browser, WHODrug Browser, or equivalent is essential.
• Leadership: Proven experience in overseeing service providers is desired, along with excellent oral and written communication skills, interpersonal skills, and leadership qualities.
• Work Environment: Ability to succeed in a virtual, global, and multi-cultural environment. Must be able to multitask, prioritize, and work effectively under pressure.
• Technical Proficiency: Good IT orientation, with proficiency in Client Office products (Excel, Word, PowerPoint) and familiarity with MS365, One Drive, and Teams.
• Regulatory Knowledge: Understanding of FDA and international regulations and GCP guidelines.

Note: This position does not involve medical billing or diagnostic coding; candidates should not apply if they do not meet the specified coding qualifications. Additionally, SOW workers cannot support another pharmaceutical company while employed , as per company policy.