(Senior) Clinical Data Coder, Sponsor-Dedicated

Iqvia; Cape Town; On-site; ZAR 300 000 - 600 000; Full time

Job summary

An established industry player is seeking a Clinical Data Coder to join their dynamic team. This role involves managing coding and data management processes for clinical trials, ensuring quality deliverables while collaborating with a Clinical Data Management team. You will provide leadership in coding, project planning, and execution, while also coordinating with Study Data Managers. Your expertise in medical dictionaries and clinical terminology will be key to delivering accurate and timely results. Join a forward-thinking company that is dedicated to improving patient outcomes and advancing healthcare through innovative research and insights.

Qualifications

• 7 years of relevant experience in clinical trials for advanced role.
• Excellent knowledge of medical dictionaries and terminology.

Responsibilities

• Manage coding and data management processes for clinical trials.
• Deliver accurate coding using MedDRA and WhoDrug dictionaries.

Skills

Clinical Trials Management

Coding using Medical Dictionaries

Quality Control

Communication Skills

Data Management Processes

Negotiation Skills

Education

High School Diploma or equivalent

Pharmacy, Dental, Medical, Nursing, Life Sciences

Tools

MedDRA

WhoDrug

EDC Systems

Job description

Job Overview

Home-based in South Africa

As a Clinical Data Coder, you will manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer’s satisfaction; provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs; provide leadership to the team in the area of coding, project planning and execution, financial management, communication and milestone tracking. You may perform the role of a Data Operations Coordinator (DOC), Data Team Lead (DTL), and a customer site lead or may be responsible for managing and delivering a program of studies for a customer.

Clinical Coding Analyst - Base:

1. In collaboration with Study Data Manager, develop coding guidelines in line with study requirements defining dictionary versions.
2. Deliver timely consistent, accurate and reproducible coding using MedDRA and WhoDrug dictionaries.
3. Perform independent quality control of coded data.
4. Address coding issues from coding QC or consistency and accuracy review.
5. Perform post-coding dictionary up-versioning synonym and coding reconciliation.
6. Synonym Maintenance
7. Perform coding set-up UAT

Clinical Coding Analyst - Advanced:

1. In collaboration with Study Data Manager, develop coding guidelines in line with study requirements defining dictionary versions.
2. Deliver timely consistent, accurate and reproducible coding using MedDRA and WhoDrug dictionaries.
3. Perform independent quality control of coded data.
4. Address coding issues from coding QC or consistency and accuracy review.
5. Perform post-coding dictionary up-versioning synonym and coding reconciliation.
6. Synonym Maintenance
7. Perform coding set-up UAT
8. Workload Management
9. Training and team coordination
10. Coordination study timelines
11. Maintain post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.
12. Perform Dictionary up-versioning activities.
13. Perform external verbatim coding of data from non-EDC sources in line with required coding dictionary versions.

Qualifications

1. High School Diploma or equivalent Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent Pref
2. 7 years (advanced role) or 3/4 years (base role) of relevant experience in clinical trials within a similar function, including proven competence in managing the delivery of coding or/and other data management processes for multiple global projects, also including experience in handling complex customer negotiations and bid defense meeting. Pref
3. Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
4. Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
5. Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice.
6. Excellent understanding of clinical drug development process (detail oriented).
7. Excellent English written and oral communication skills.
8. Ability to work on computer systems with ease and good working knowledge of computer programs.
9. Able to establish trust and collaborative relationships with customers.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com