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Clinical Trial Manager
Posted about 1 month agoViewed
💎 Seniority level: Manager, 5 years minimum
💸 Salary: 85000.0 - 140000.0 USD per year
🔍 Industry: Medical Technology
🏢 Company: Heartflow
🗣️ Languages: English
⏳ Experience: 5 years minimum
Requirements:
- Bachelor’s degree in science or health related field
- Demonstrated 5 years minimum relevant experience required
- Experience in cardiovascular medical device clinical research a plus
- Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
- Excellent written and oral English communication skills required
- Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint
Responsibilities:
- Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
- Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
- Participates in and leads process improvement activities within the department and cross functionally, including SOP development
- Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
- Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
- Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
- Perform other duties as required for successfully completing studies, as necessary
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