Clinical Data Coder

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead and accurately code medical terms and medications utilizing MedDRA, WHO Drug, and internal guidelines.

• Supervise the setup of coding modules for assigned studies, including configurations and workflows.

• Define, document, and manage coding conventions and synonym lists.

• Validate sponsor coding licenses.

• Serve as the Lead Coder for multiple studies concurrently.

• Manage coding priorities and workloads across various timelines and studies.

• Contribute to the Coding section of Data Management Plans.

• Oversee and execute dictionary version upgrades and related tasks.

• Validate and test coding setups, coding report programming, and database validations.

• Support data review processes and promptly address data clarifications.

• Communicate effectively with Data Management Leads, CRAs, and other stakeholders.

• Conduct clinical data coding and manage clinical data activities in adherence to regulations, industry standards, SOPs, sponsor requirements, and timelines.

⛳️ Requirements

• Bachelor’s degree or equivalent education in pharmacy, life sciences, or a related field.

• Medical or nursing qualification with at least 2 years of relevant experience, or a comparable combination of education, training, and experience.

• Comprehensive knowledge of medical terminology and coding dictionaries, including MedDRA and WHODD.

• Preferred experience in clinical trials or the pharmaceutical sector.

• Understanding and experience with the query management process.

• Ability to work flexibly on multiple projects and proactively manage time to meet deadlines.

• Exceptional written and verbal communication skills in English.

• Capability to collaborate effectively in a global team environment.

• Strong organizational and analytical skills with high attention to detail.

• Familiarity with good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must possess legal eligibility to work in Canada.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Comprehensive company benefits package.

• Continuous learning and development opportunities.

• Home-based position.

• Comprehensive benefits (medical, dental, vision care, RRSP, vacation, personal days, virtual medical clinic, transit discounts, social activities).