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Clinical Operations Study Country Lead I(m/w/x)
Description
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •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
Education
Work Experience
approx. 4 - 6 years
Tasks
- •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 & Technologies
Languages
German – Business Fluent
English – Business Fluent
Benefits
Healthcare & Fitness
- •High-quality healthcare
Other Benefits
- •Numerous prevention programs
Job Security
- •Long-term illness coverage
Generous Parental Leave
- •14-week paid family leave
Childcare
- •Wide range of childcare benefits
Flexible Working
- •Hybrid working models
- •Flexible working time models
- Sanofi-Aventis Deutschland GmbHFull-timeWith HomeofficeExperiencedFrankfurt am Main
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Clinical Operations Study Country Lead I(m/w/x)
The AI Job Search Engine
Description
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •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
Education
Work Experience
approx. 4 - 6 years
Tasks
- •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 & Technologies
Languages
German – Business Fluent
English – Business Fluent
Benefits
Healthcare & Fitness
- •High-quality healthcare
Other Benefits
- •Numerous prevention programs
Job Security
- •Long-term illness coverage
Generous Parental Leave
- •14-week paid family leave
Childcare
- •Wide range of childcare benefits
Flexible Working
- •Hybrid working models
- •Flexible working time models
About the Company
Sanofi-Aventis Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
- Sanofi-Aventis Deutschland GmbH
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