Sanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead I(m/w/x)
Full-timeWith HomeofficeSenior
Frankfurt am Main
New Job?Nejo!
Your personal AI career agent
SASanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
AI/ML
Data Science
Nejo AI Summary
Country-level operational lead for biopharma clinical studies, managing timelines and budgets. AI expertise and GCP certification required. 14-week paid family leave, childcare benefits.
Requirements
- AI expertise and data-driven thinking
- University degree in medicine, pharmacy, biology, biochemistry or related natural science
- Experience in clinical research, project management, or field monitor/site-coordinator
- Solid knowledge of clinical development process and relevant therapeutic/disease area(s); GCP certificate
- Strong project management skills
- Data analytic skills and use of digital tools, platforms and systems
- Problem-solving and risk-management skills in clinical study environment
- Change management skills
- Interpersonal skills with ability to create and foster trustful relationships
- Willingness to travel ~ 10-20%
- Fluent German and English
Tasks
- Own country-level operational lead for clinical studies
- Accountable for strategic planning of clinical trials
- Manage performance of assigned clinical trials
- Oversee study timelines at country level
- Manage study budget at country level
- Ensure study conduct per SOPs and guidelines
- Act as strategic hub at country level
- Connect internal and external stakeholders
- Accelerate trial execution
- Represent CSU in Core Study Team meetings
- Report to CSU Team Lead
- Partner with COSL on study matters
- Deliver study as planned at CSU level
- Consult or escalate operational issues
- Develop local study strategy
- Initiate recruitment strategies
- Initiate retention strategies
- Identify successful site mapping
- Set up site engagement plans
- Organize local kick-off meetings
- Lead set-up activities
- Manage local study performance
- Ensure compliance with timelines
- Drive performance with risk assessment
- Manage site engagement
- Support site staff
- Escalate issues as needed
- Collaborate on budget preparation
- Manage financial resources
- Address budget-related issues promptly
- Act as main link to local monitoring team
- Collaborate with Vendor Functional Line Managers
- Plan engagement activities
- Participate in engagement activities
- Coordinate local team meetings
- Establish collaboration with Medical Affairs
- Maintain data quality
- Ensure patient safety
- Ensure compliance with study metrics
- Ensure CRA training
- Collaborate on audit activities
- Ensure system readiness
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- AI
- digital tools
- platforms
- systems
- GCP
Benefits
Healthcare & Fitness
- High-quality healthcare
Mental Health Support
- Prevention programs
Job Security
- Long-term illness coverage
Generous Parental Leave
- 14-week paid family leave
Childcare
- Childcare benefits
Modern Office
- Modern working environment
Flexible Working
- Hybrid flexible working hours
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.
Not a perfect match?
- Sanofi-Aventis Deutschland GmbH
Clinical Study Unit (CSU) Cluster Head GSA(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - ICON plc
Clinical Trial Manager(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - IQVIA
Associate Manager or Manager, Clinical Operations(m/w/x)
Full-timeRemoteManagementFrankfurt am Main - IQVIA
Manager Clinical Operations, Single Sponsor(m/w/x)
Full-timeRemoteSeniorFrankfurt am Main
SASanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
AI/ML
Data Science
Nejo AI Summary
Country-level operational lead for biopharma clinical studies, managing timelines and budgets. AI expertise and GCP certification required. 14-week paid family leave, childcare benefits.
Requirements
- AI expertise and data-driven thinking
- University degree in medicine, pharmacy, biology, biochemistry or related natural science
- Experience in clinical research, project management, or field monitor/site-coordinator
- Solid knowledge of clinical development process and relevant therapeutic/disease area(s); GCP certificate
- Strong project management skills
- Data analytic skills and use of digital tools, platforms and systems
- Problem-solving and risk-management skills in clinical study environment
- Change management skills
- Interpersonal skills with ability to create and foster trustful relationships
- Willingness to travel ~ 10-20%
- Fluent German and English
Tasks
- Own country-level operational lead for clinical studies
- Accountable for strategic planning of clinical trials
- Manage performance of assigned clinical trials
- Oversee study timelines at country level
- Manage study budget at country level
- Ensure study conduct per SOPs and guidelines
- Act as strategic hub at country level
- Connect internal and external stakeholders
- Accelerate trial execution
- Represent CSU in Core Study Team meetings
- Report to CSU Team Lead
- Partner with COSL on study matters
- Deliver study as planned at CSU level
- Consult or escalate operational issues
- Develop local study strategy
- Initiate recruitment strategies
- Initiate retention strategies
- Identify successful site mapping
- Set up site engagement plans
- Organize local kick-off meetings
- Lead set-up activities
- Manage local study performance
- Ensure compliance with timelines
- Drive performance with risk assessment
- Manage site engagement
- Support site staff
- Escalate issues as needed
- Collaborate on budget preparation
- Manage financial resources
- Address budget-related issues promptly
- Act as main link to local monitoring team
- Collaborate with Vendor Functional Line Managers
- Plan engagement activities
- Participate in engagement activities
- Coordinate local team meetings
- Establish collaboration with Medical Affairs
- Maintain data quality
- Ensure patient safety
- Ensure compliance with study metrics
- Ensure CRA training
- Collaborate on audit activities
- Ensure system readiness
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- AI
- digital tools
- platforms
- systems
- GCP
Benefits
Healthcare & Fitness
- High-quality healthcare
Mental Health Support
- Prevention programs
Job Security
- Long-term illness coverage
Generous Parental Leave
- 14-week paid family leave
Childcare
- Childcare benefits
Modern Office
- Modern working environment
Flexible Working
- Hybrid flexible working hours
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.
Not a perfect match?
- Sanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead I(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Clinical Study Unit (CSU) Cluster Head GSA(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - ICON plc
Clinical Trial Manager(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - IQVIA
Associate Manager or Manager, Clinical Operations(m/w/x)
Full-timeRemoteManagementFrankfurt am Main - IQVIA
Manager Clinical Operations, Single Sponsor(m/w/x)
Full-timeRemoteSeniorFrankfurt am Main