Coding Specialist

Role Information

As a Coding Specialist (Clinical Data Associate I), you will join their Functional Service Provider (FSP) team at the forefront of clinical research. You will ensure high-quality, compliant coding of clinical and medical terminology using established standards and study-specific Coding Plans. This role is critical in delivering accurate, analysis-ready data to help bring life-changing medicines to market.

Key Responsibilities

1. Medical Coding: Perform coding of medical terminology and review coding listings in accordance with the Coding Plan in the Data Validation Manual (DVM).

2. Data Integrity: Identify data issues and collaborate with study teams and clinical sites to resolve discrepancies.

3. Compliance: Ensure all coding deliverables align with departmental Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory guidelines.

4. Project Support: Provide guidance on coding aspects to the Clinical Data Management (CDM) project team and maintain comprehensive documentation.

5. Reporting: Produce project-specific status reports for supervisors and clients to ensure inspection-readiness.

6. Quality Management: Deliver accurate coding outputs within budget and on-time, maintaining a high degree of confidentiality.

Qualifications & Experience

1. Education: Bachelor’s degree or equivalent in a relevant scientific or health-related field.

2. Experience: Minimum of 1 to 1.6 years of experience in clinical data coding or a related CDM role.

3. Technical Skills: Proficiency in RAVE or Veeva EDC systems.

4. Dictionary Knowledge: Strong experience with WHODD (WHO Drug Dictionary) and MedDRA (Medical Dictionary for Regulatory Activities).

5. Soft Skills: Excellent command of English (written and verbal), strong analytical problem-solving skills, and the ability to work independently in a remote team environment.