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Sanofi-Aventis Deutschland GmbH
15d ago

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

Frankfurt am Main
Full-timeWith Home OfficeSenior
AI/ML

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.

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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

Bachelor's degree
OR
Master's degree

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

Data analyticsDigital toolsDigital platformsDigital systems

Languages

GermanBusiness Fluent

EnglishBusiness 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
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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