Senior Clinical Research Monitor(m/w/x)

Beschreibung

You will drive the execution of clinical studies across the EMEA region by managing complex monitoring activities and ensuring the safety and efficacy of diabetes medical devices.

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

Benefits