Clinical Supply & Trial Coordinator

Lesaffre; Town of Italy (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Lesaffre Iberica SA is seeking a Clinical Trial and Supply Coordinator for their Substantiation team in Town of Italy, New York. The role involves planning, coordinating, and overseeing the execution of supply for clinical studies, acting as the point of contact between various teams. The ideal candidate will manage supply chain logistics and support clinical study management activities, ensuring compliance with regulations. Candidates should possess strong project management and supply chain coordination skills.

Qualifications

• Experience in managing clinical supplies and logistics.
• Strong understanding of GMP and GCP regulations.
• Ability to coordinate with multiple teams and external partners.

Responsibilities

• Plan and oversee execution of investigational product supply.
• Coordinate communication and deliverables with CMOs.
• Ensure compliance with regulatory and logistical requirements.

Skills

Project management

Supply chain coordination

Regulatory compliance

Cross-functional collaboration

Clinical trial support

Job description

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, distribution, returns/destruction of the investigational product
• Act as supply chain owner for the investigational product (study set up, manufacturing plan, shipment, product assignment)
• Support demand forecasting and supply planning for investigational product

Vendor & CMO Management

• 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, packaging, labelling, batch documentation, release and inventory control of the investigational product
• Manage IP distribution in partnership with the Supply and Logistics team

Logistics and distribution

• Coordinate clinical batch production, QC, stability sample and shipments
• Serve as POC for clinical site shipment and query resolution
• Ensure adherence to GMP, GCP and import/export requirements

  Cross-functional collaboration

  • 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

  Clinical Study Management Support

  • Contribute to clinical trial with study planning and execution
  • Support study start-up activities (e.g. contracts, regulatory submissions)
  • Maintain study trackers and dashboards
  • Organize meetings, agendas and minutes
  • Maintain Sponsor essential documents and support inspection readiness