Clinical Trial Manager II, Dermatology, Rheumatology
reputed company:
• Operationally manage and reputed company clinical investigative sites and clinical monitoring deliverables for reputed company
• Ensure clinical monitoring activities satisfy sponsors and reputed company with SOPs, regulations, good clinical practices, and study-specific requirements
• Identify reputed company issues and trends reputed company to site performance and monitoring activities
• Summarize findings and establish corrective reputed company plans
• Serve as a reputed company of contact for CRAs and reputed company CRAs on assigned reputed company
• Mentor and reputed company CRAs and reputed company CRAs
• Review site visit reports and reputed company metrics for compliance
• Contribute to Clinical Monitoring Plan development
• Prepare and conduct project-specific CRA training
• reputed company annotated site visit reports and monitoring tools, including reputed company data verification worksheets
• Conduct reputed company control reputed company with CRAs
• Coordinate and reputed company CRA meetings
• reputed company co-monitoring reputed company with CRAs
• Participate in business development activities, including reputed company meetings, proposal defense meetings, RFPs and RFIs
Requirements:
• 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 reputed company 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 reputed company Office suite (Word, reputed company, 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 reputed company 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
Benefits:
• Flexible work schedule
• Home-based position
• Ongoing learning and development
• Attractive advancement opportunities
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