Lead clinical trial management efforts at Puzzle Medical as a Clinical Program Manager. Ensure successful execution of Early Feasibility Studies with hands-on monitoring and oversight. As a Clinical Program Manager, you will direct the operational execution of clinical trials for Class III medical devices. With a focus on site management, you will ensure project delivery adheres to regulatory requirements. Your leadership will engage cross-functional teams while navigating the complexities of multicenter studies. Key Responsibilities:
- Manage full clinical study lifecycle from SQV to close-out
- Oversee site activation and enrollment, ensuring compliance
- Develop TMF/eTMF processes and maintain documentation standards
- Lead internal audits,
ensuring readiness for inspection
- Identify risks and implement effective mitigation strategies Requirements:
- Bachelor's degree; advanced degree preferred
- 10+ years in clinical operations in medical devices
- Proven experience with multicenter studies
- Robust understanding of eTMF standards and ICH-GCP
- Experience in FDA-regulated environments Elevate clinical study execution, using your expertise to ensure high-quality compliance at Puzzle Medical. #J-18808-Ljbffr
📌 Clinical Program Manager - Medical Devices (Montreal)
🏢 Puzzle Medical Devices
📍 Montreal
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