
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.
• Provide support for coding of clinical data for ongoing clinical studies • Participate in clinical data management activities to ensure data are collected, managed and reported clearly, accurately and securely • Conduct activities in accordance with regulatory requirements, industry guidelines, SOPs, sponsor requirements and timelines • 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 • Manage coding priorities and workload across timelines and studies • Provide input to the Coding section of Data Management Plans • Oversee and perform dictionary up-versioning and upgrades • Validate and test coding setups, coding reports and database checks • Support data review activities and resolve data clarifications • Communicate with Data Management Leads, CRAs and other stakeholders
• 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, such as MedDRA and WHODD • Experience working with clinical trials or within the pharmaceutical environment is preferred • Understanding and experience in query management processes • 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 • Good knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines • Must be legally authorized to work in India • Attendance at some meetings outside regular business hours, primarily in the evening
• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities • Home-based work arrangement
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