Senior Clinical Research Monitor(m/w/x)

Anforderungen

• Degree in life sciences, healthcare, or equivalent
• Experience in clinical monitoring, operations, or study management
• Strong project coordination and attention to detail
• Problem solving mindset and pro-active attitude
• Ability to work with minimal supervision
• Strict adherence to procedures, SOPs, and regulations
• Flexibility and strong adaptability to change
• Willingness to travel approximately 25%
• Customer focused team player
• Mature personality and inclusive collaboration skills
• Ability to cultivate relationships
• Curiosity and creative thinking
• Fluent English communication skills
• Ability to manage multiple tasks
• Strong quality focus

Aufgaben

• Coordinate and execute all clinical trial monitoring activities
• Follow SOPs, GCP guidelines, and country-specific regulations
• Develop and maintain monitoring study documentation
• Implement risk-based monitoring and targeted source data verification
• Plan and coordinate monitoring visit schedules
• Review monitoring visit reports and action items
• Escalate monitoring issues and coordinate their resolution
• Perform quality checks to ensure audit and inspection readiness
• Manage centralized monitoring and clinical device accountability
• Support study start-up activities with the study manager
• Prepare investigator meetings and site initiation visits
• Train the monitoring team and hospital staff
• Collaborate with internal and external stakeholders
• Oversee vendor and CRO monitoring activities

Ausbildung

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