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Associate imp manager (m|f|d)

Bergisch Gladbach
Miltenyi Biomedicine
Manager
Inserat online seit: 13 Oktober
Beschreibung

Job Description You are working in the department “Clinical Development Europe” which is performing clinical trials in the field of cellular therapies. As an Associate IMP Manager, you will be part of in the Clinical Trial Execution Service group working closely with the IMP Managers to support the operational daily business regarding Investigational Medicinal Products topics within the clinical trials. As an Associate IMP Manager, you will support the planning, execution, and documentation of apheresis and Investigational Medicinal Product (IMP) processes to ensure regulatory compliance and efficient delivery throughout the product lifecycle, from collection to application or destruction. You will assist in managing the lifecycle of comparator drugs and IMPs, including labeling, packaging, IWRS setup, distribution, drug accountability, and demand planning across multiple clinical trials. You will monitor and document deviations such as Out of Specification (OoS) events, escalate issues to relevant stakeholders, and support the implementation and documentation of corrective actions in collaboration with Clinical Trial Coordination and Quality Assurance. You will contribute to the development and maintenance of manuals, SOPs, and working procedures, and support training and communication with internal teams, apheresis sites, and Contract (Development) Manufacturing Organizations (C[D]MOs). You will act as a point of contact for IMP-related questions from internal and external trial teams, support process improvement initiatives, and ensure that all relevant documentation is properly filed in the Trial Master File (TMF).

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