Data Management Medical Coders (Kiev/Kharkiv)

Intego Group’s Biometric Department is expanding its clinical data management practice. We’re looking for bright individuals to join our growing team in Kyiv and Kharkiv offices as a Data Management Medical Coders.

Our client is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, their scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value, and unlock the full potential of their data.

Summary:

Data Management Medical Coder will be responsible for coding functions in accordance with clients and/or Sponsor Standard Operating Procedures (SOPs), guidelines, and global standards, maintain coding integrity and ensure consistency across all projects and collaborates with Data Management (DM) to ensure timely completion of coding tasks.

Responsibilities:

• Perform coding using MedDRA and WHO Drug, or other Client/Sponsor specified dictionaries using web-enabled dictionary and coding management system or other system as required.
• Perform Coding in accordance with study specific coding conventions as outlined in the Data Management Plan (DMP) for assigned projects and according to Client/Sponsor specifications. 
• Collaborate with Data Management to ensure coding consistency, completeness, and accuracy of assigned coding projects.
• Identify coding changes, perform re-coding and dictionary up-versioning when needed.
• Identify issues in data, create data queries and/or notify lead DM of any inconsistencies that needs Clinical/Sponsor team.
• Be aware of project timelines and complete coding tasks as per timelines.
• Assist DM in other coding-related tasks as required by the project.

 Skills and Qualifications:

• A minimum of a Medical, Pharmacy/Nursing or Life Science Bachelor's degree. A Masters is preferred.
• 1-2 years hands on relevant career experience in the pharmaceutical or biotechnology industry.
• Good understanding of medical terminology.
• MedDRA and WHO trainings/certification.
• Basic understanding of the FDA/ICH-GCP guidelines, Title 21 CFR Part 11, and other relevant regulations.
• Must understand the role of all the functional areas in the clinical trial process.

 Communication:

• The candidate should demonstrate clear and timely written and verbal communication with peers, customers, and management.
• Candidate should have at least an upper-intermediate level of English.