Sanofi-Aventis Deutschland GmbH
Clinical Study Unit (CSU) Cluster Head GSA(m/w/x)
Full-timeWith HomeofficeExperienced
Frankfurt am Main
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SASanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead I(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
AI/ML
Nejo AI Summary
Leading country-level clinical study initiation and patient recruitment for cardiovascular medicines. Mandatory clinical research experience; project management background preferred. 14-week paid family leave, extensive childcare benefits.
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
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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Data analytics
- Digital tools
- Digital platforms
- Digital systems
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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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SASanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead I(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
AI/ML
Nejo AI Summary
Leading country-level clinical study initiation and patient recruitment for cardiovascular medicines. Mandatory clinical research experience; project management background preferred. 14-week paid family leave, extensive childcare benefits.
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
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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Data analytics
- Digital tools
- Digital platforms
- Digital systems
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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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.
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