Lesaffre
Biotechnology
ClinicalSupply&TrialCoordinator
Neural analysis suggests this role is
optimal for entry candidates.
“Clinical Supply & Trial Coordinator at Lesaffre. Skills: Clinical Supply Execution, Vendor & CMO Management, Logistics and distribution, Cross-functional collaboration, Clinical Study Management Support. Planning and translation of study requirements into operational supply and distribution plans. Coordinate the clinical squad to define and plan investigational product supply strategy”
What You'll Achieve.
ensure the timely availability of clinical materials; adherence to all regulatory requirements; successful delivery of Gnosis' clinical programs; ensure execution of plans to ensure product readiness
Industry & Context.
Good problem-solving skills
Travel Expectation: 10-20% of the time
What They're Looking For.
Must Have
Bachelor’s or master’s degree in Pharmacy or Pharmaceutical chemistry or a life-science related field, 2-4 years of experience in a related supply chain or clinical supply role, Experience in clinical trial operations, expertise in project management and use of project management tools, organizational skills and attention to detail, Ability to manage timelines under pressure, Good problem-solving skills, Proficiency in English is essential
Nice to Have
Functional experience in clinical supply manufacturing, labelling, packaging and supply, knowledge of another global language is an asset
What You'll Do.
Planning and translation of study requirements into operational supply and distribution plans
Coordinate the clinical squad to define and plan investigational product supply strategy
returns/destruction of the investigational product
Act as supply chain owner for the investigational product (study set up
Support demand forecasting and supply planning for investigational product
Act as the point of contact for CMO day-to-day coordination and deliverable tracking
Support CMO communication and product technical specification alignment process
Monitor manufacturing
release and inventory control of the investigational product
Manage IP distribution in partnership with the Supply and Logistics team
Coordinate clinical batch production
stability sample and shipments
Serve as POC for clinical site shipment and query resolution
Ensure adherence to GMP
GCP and import/export requirements
Contribute to clinical trial with study planning and execution
Support study start-up activities (e.g. contracts
regulatory submissions)
Maintain study trackers and dashboards
Maintain Sponsor essential documents and support inspection readiness
How You'll Work.
Team & Collaboration
Act as the central point of contact between the Substantiation team, other cross-functional production team within Gnosis and CMOs; Act as the interface between CMO, CRO and internal cross functional teams; Align with Regulatory, Quality, Logistics and Formulation teams on project progress and ensure execution of plans to ensure product readiness; Supports cross-functional resolution of risks to clinical product manufacturing and supply
Communication Scope
Proficiency in English is essential
Process & Methodology
project management, project management tools, Ability to manage timelines under pressure
Full Job Description
Gnosis by Lesaffre aims to raise the standard of human health and build a world where proactive health solutions empower people to live longer, happier lives. By exploring the world of microorganisms, we tap into nature’s biological processes to develop solutions that address pressing health challenges while promoting positive impact on both human and planetary health. Together with nutraceutical and pharmaceutical brands, we develop revolutionary products that help their customers thrive. Our vision is a future where health is proactive, solutions are sustainable, and the timeless wisdom of nature guides every step forward. Think like Nature to Raise human health. At Gnosis, a Lesaffre subsidiary, we are committed to human health and nutrition with the ambition to better nourish and protect the planet. Our Substantiation Science team is looking for a passionate Clinical Trial and Supply Coordinator to join our Substantiation team within Scientific Affairs department. As a Clinical Trial and Supply Coordinator, you will be responsible for planning, coordinating, and overseeing the execution of investigational product supply and distribution for Gnosis' clinical studies. You will act as the central point of contact between the Substantiation team, other cross-functional production team within Gnosis and CMOs to ensure the timely availability of clinical materials and adherence to all regulatory requirements. Additionally, you will provide support for clinical study management activities, contributing to the successful delivery of Gnosis' clinical programs. The Clinical Trial and Supply Coordinator will report to the Substantiation Director with close interactions with the Clinical Project Manager. Activities Clinical Supply Execution * Planning and translation of study requirements into operational supply and distribution plans * Coordinate the clinical squad to define and plan investigational product supply strategy * Oversee packaging, labelling, QP release, distri
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