Clinical Data Coder leading medical and medication coding for Indero’s global dermatology and rheumatology clinical trials. Managing coding setups, dictionaries, data reviews, and study timelines.
Responsibilities
Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions
Oversee coding module setup for assigned studies, including configurations and workflows
Define, document, and manage coding conventions and synonym lists
Validate sponsor coding licenses
Act as Lead Coder across multiple studies simultaneously
Manage coding priorities and workload across timelines and studies
Provide input to the Coding section of Data Management Plans
Oversee and perform dictionary version upgrades and related activities
Validate and test coding setups, coding report programming, and database checks
Support data review activities and resolve data clarifications promptly
Communicate with Data Management Leads, CRAs, and other stakeholders
Perform clinical data coding and clinical data management activities in compliance with regulations, industry guidelines, SOPs, sponsor requirements, and timelines
Requirements
Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field
Medical or nursing qualification with 2 years relevant experience, or equivalent combination of education, training and experience
Thorough knowledge of medical terminology and medical dictionaries used for coding, including MedDRA and WHODD
Experience with clinical trials or within the pharmaceutical environment is preferred
Understanding and experience in query management process
Ability to work flexibly on simultaneous projects and proactively manage time to meet deadlines
Excellent written and verbal English communication skills
Ability to work in a global team environment
Good organizational and analytical skills and high attention to detail
Knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines
Must be legally able to work in Canada
Benefits
Flexible work schedule
Permanent full-time position
Company benefits package
Ongoing learning and development
Home-based position
Avantages sociaux complets (soins médicaux, soins dentaires, soins de la vue, REER, vacances, jours personnels, clinique médicale virtuelle, rabais sur le transport en commun, activités sociales)
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