Clinical Data Coder (Home/Office-Based) - IQVIA Biotech

POSITION TITLE: Clinical Coder

REPORTS TO: Associate Director, Data Management/Manager, Data Management or Designee

BASIC FUNCTIONS:

Clinical Coder position is to perform medical coding for a data management project per industry standards and client specifications.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Performs Medical Coding:
  • Codes with the highest level of quality using MedDRA and WHO Drug medical dictionaries
  • Query medical terminology for improved ability to code
  • Reviews coding for consistency
  • Provides listings of coded terms for medical review
• Coded Data and Query Review:
  • Creates listings using ad hoc query tools
  • Issues queries and review query responses with the highest level of quality based upon the Data Review Plan, Medical Coding, Aggregate Checks (DM listings) with coding information, and SAE reconciliation
  • Assists other data reviews using coding data for Biostatistics, Medical Review, client, and other ad hoc reports
• Coding System Set-up and Maintenance:
  • Communicates with project team and client for medical coding guidelines
  • Provides coding input on CRF design, edit check specification and data review plan
  • Configures and Updates the coding system as needed for the study
  • Provides feedback to the Lead DM and Programmers to improve the deliverables.
• Documentation:
  • Creates and Updates DM study documents as related to coding including coding initiation forms, coding guidelines, DMP (along with supporting DM documents), CRF Completion guidelines, data entry guidelines, trial design documents, edit specifications, SAE reconciliation guidelines, and report specifications.
  • Creates and Updates corporate documentation as related to coding including SOPs/WPs.

• Assists DM Lead:
  • Provides feedback to improve the system or reports.
  • Discusses roadblocks for getting processes done in a timely manner.
  • Produces Coding Metric reports to provide to internal/external project team.
  • Reviews project budgets and staffing projections for coding allocation.
  • Provides the DM lead with status updates on coding or other tasks as delegated.

KNOWLEDGE, SKILLS AND ABILITIES:

• Team player with ability to work well with technical and clinical team members
• Ability to communicate effectively with Medical Monitor and other key members of the team.
• Knowledge of clinical trials data processing concepts
• Comprehension of clinical study documents (CRF guidelines, protocol, etc) and SOPs/WPs
• Proficiency with data management coding systems (preferred systems are dsNavigator, Oracle TMS, or specific EDC coding platforms)
• Efficiency and organizational skills to meet deadlines
• Good communications skills, verbal, written and listening
• Willingness to learn new things and teach others
• Ability to accept constructive criticism
• Organized and thorough with attention to details
• Ability to adhere to detailed instructions
• Logical thinking ability regarding problem-solving skills
• Ability to prioritize
• Proficiency in computer applications (Windows, Excel, Word, Outlook etc.)
• Ability to work independently

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very little physical effort required to perform normal job duties (unless otherwise indicated)

MINIMUM RECRUITMENT STANDARDS:

• Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and
• 5 years of clinical data management experience in pharmaceutical industry and/or contract research organization

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

In compliance with the Colorado Equal Pay For Equal Work Act, salary range is displayed - Salary Pay Range: $53,900 - $70,000