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Expertly delivering clinical trials operations, with care.
Clinical Study Supply Manager
Location
France
Posted
94 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Clinical Study Supply Manager
Excelya
Role Description This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. - Ensure timely, cost-effective, and quality-compliant delivery of clinical study supplies for CHC clinical studies - Coordinate the sourcing of clinical study drug products (placebo, investigational and marketed products) in collaboration with CMOs, CHC Development Centers, and IA sites - Manage clinical supplies budget, including forecasting and invoice tracking with CMOs - Oversee CMOs to ensure effective execution of clinical supply operations in line with study requirements - Define and implement the optimal clinical supply strategy for each study and ensure clear communication to study teams - Monitor clinical supply production plans and ensure alignment with study timelines - Lead Operational Supply Meetings with CMOs to track progress, anticipate issues, and adjust supply strategies to mitigate risks - Review and contribute to study-related documentation (protocols, pharmacy manuals, monitoring and communication plans) to optimize supply usage - Ensure proper oversight of clinical supply documentation within the (e)TMF - Identify and mitigate clinical supply-related risks as part of the study risk management approach - Contribute, as needed, to broader clinical study management activities, including process improvement and coordination of external collaborations Qualifications - Minimum 10 years of experience as Clinical Study Support Manager - Solid understanding of GxP regulations and clinical trial operations - Master's degree in the related field - Fluent in French and in English Benefits - Environment that values your natural talents - Opportunity to push boundaries with audacity - Nurturing your potential, allowing you to contribute fully to our shared mission
Job Requirements
- Minimum 10 years of experience as Clinical Study Support Manager
- Solid understanding of GxP regulations and clinical trial operations
- Master's degree in the related field
- Fluent in French and in English
Benefits
- Environment that values your natural talents
- Opportunity to push boundaries with audacity
- Nurturing your potential, allowing you to contribute fully to our shared mission
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