
201 - 500 employees
💊 Pharmaceuticals
🏥 Healthcare
💼 Consulting
Pharmaceuticals • Healthcare • Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
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201 - 500 employees
💊 Pharmaceuticals
🏥 Healthcare
💼 Consulting
Pharmaceuticals • Healthcare • Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
• Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions • Oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows • Define, document, and manage coding conventions and ensure consistent application across studies • Act as the Lead Coder, coordinating coding activities across multiple studies simultaneously • Validate sponsor coding licenses • Manage coding priorities, balancing workload across timelines and studies • Provide input to the Coding section of Data Management Plans • Oversee and perform dictionary up-versioning and related upgrade activities • Validate and test coding setups, programming of coding reports, and related database checks • Support data review activities and resolve data clarifications in a timely manner • Provide mentorship and guidance to junior or back-up coders • Actively contribute to process optimization, SOP development, and best practices in coding • Maintain effective communication with Data Management Leads, CRAs, and other stakeholders • Attend some meetings outside regular business hours, primarily in the evening
• Bachelor’s degree or equivalent in pharmacy, life sciences, or a related field (medical/nursing background also acceptable) • Minimum of 5 years’ relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO environment • Thorough knowledge of medical terminology and medical dictionaries (MedDRA, WHO Drug) • Demonstrated experience with coding module setup, management of conventions, and prioritization of tasks across multiple studies • Experience in query management and clinical data review • Proven ability to manage multiple studies concurrently • Excellent written and verbal English communication skills • Strong organizational and analytical skills with high attention to detail • Ability to lead within a global team environment, providing guidance to colleagues and ensuring deliverables are met • Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines • Must be legally able to work in India
• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities
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