Clinical Operations Study Country Lead I(m/w/x)

Beschreibung

You will drive clinical breakthroughs by leading country-level study strategies, managing budgets, and ensuring operational excellence from site setup through to high-quality data collection.

Anforderungen

• •Business fluent German and English
• •Experienced or Senior Project Manager
• •Degree in medicine, pharmacy, or natural science
• •Mandatory clinical research experience
• •Preferred project management and monitoring background
• •Knowledge of clinical development processes
• •Strong project management skills
• •Excellent problem-solving and risk-management capabilities
• •Proficiency in data analytics and digital tools
• •Change management skills and adaptability
• •Outstanding interpersonal and relationship-building skills
• •Fluency in English and German
• •Willingness to travel up to 10%
• •Strong understanding of ICH/GCP and regulations

Aufgaben

• •Develop and execute local study country strategies
• •Lead country start-up and study initiation activities
• •Create early recruitment and retention strategies
• •Identify site mapping and site engagement strategies
• •Organize local kick-off meetings
• •Manage study performance and compliance at the local level
• •Utilize project management tools like CTMS and Control room
• •Implement proactive risk assessment and mitigation strategies
• •Represent the Clinical Study Unit at core team meetings
• •Provide strategic support to site staff and monitoring teams
• •Optimize and maintain study budgets at the country level
• •Collaborate on Local Study Budget Form preparation
• •Escalate budget risks and initiate necessary updates
• •Act as the primary interface between global and local teams
• •Partner with vendors to drive quality and KPIs
• •Coordinate with Medical Advisors and Site Engagement Leads
• •Collaborate with Medical Affairs on trial conduct
• •Ensure data quality, patient safety, and metric compliance
• •Oversee data collection and query resolution processes
• •Support audit and inspection activities
• •Maintain system readiness for PAI, TMF, and CTMS
• •Ensure CRA training compliance

Tools & Technologien

Benefits