
201 - 500 employees
đź’Š Pharmaceuticals
🏥 Healthcare
đź’Ľ 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.
🔥 0 minutes ago
🇺🇸 United States – Remote
⏰ Full Time
đźź Senior
đź”´ Lead
đź§Ş Clinical Research
đź‘» Ghost score 12%
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201 - 500 employees
đź’Š Pharmaceuticals
🏥 Healthcare
đź’Ľ 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.
• Operationally manage and oversee clinical investigative sites and clinical monitoring deliverables for clinical trials • Ensure clinical monitoring activities satisfy sponsors and comply with SOPs, regulations, good clinical practices, and study-specific requirements • Identify quality issues and trends related to site performance and monitoring activities • Summarize findings and establish corrective action plans • Serve as a point of contact for CRAs and Lead CRAs on assigned projects • Mentor and oversee CRAs and Lead CRAs • Review site visit reports and track metrics for compliance • Contribute to Clinical Monitoring Plan development • Prepare and conduct project-specific CRA training • Develop annotated site visit reports and monitoring tools, including source data verification worksheets • Conduct quality control visits with CRAs • Coordinate and lead CRA meetings • Perform co-monitoring visits with CRAs • Participate in business development activities, including client meetings, proposal defense meetings, RFPs and RFIs
• B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience • At least 8 years of clinical research experience, including prior monitoring experience • At least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or CRO industry • Strong knowledge of ICH/GCP standards and applicable regulatory requirements • Excellent mastery of Microsoft Office suite (Word, Excel, PowerPoint) • Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites and sponsors • Excellent leadership, organizational, time management and multi-tasking skills • Excellent judgement and problem-solving skills • Occasional travel up to 10% of the time, including some travel outside of the country once possible • Fluent in English, with excellent oral and written proficiency • Experience in a CRO and in dermatology is an asset • Must be legally authorized to work in the US
• Flexible work schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities
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