Clinical Trial IMP Manager

vor 4 Wochen

Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit
Job Title: Clinical Trial IMP Manager

We are seeking a highly skilled Clinical Trial IMP Manager to join our team at Miltenyi Biomedicine. As a key member of our Clinical Trial Execution Service department, you will play a critical role in supporting our study processes and activities in line with our go-to-market strategy for investigational medicinal products (IMPs), particularly in haematological and oncological indications.

Key Responsibilities:
  • Plan, coordinate, and execute IMP-related trial processes and activities, including Chain of Identity (CoI) and Chain of Custody (CoC) management, to ensure efficient and compliant supply of fresh and frozen IMP.
  • Support the implementation of IMP-related processes in collaboration with the Clinical Supply Chain department, focusing on the orchestration of logistics processes critical to the product flow of our CAR-T clinical trials.
  • Develop, maintain, and optimize the necessary manuals and workflows for all relevant IMP processes, contributing to other IMP-related documents as required.
  • Oversee and support the coordination of processes and tracking of out-of-specification (OoS) products during clinical trials, documenting and escalating major IMP deviations and issues to appropriate stakeholders.
  • Participate in process improvement activities related to the IMP testing process and support the qualification, training, and monitoring of the Contract Manufacturer (CMO) supplying the IMPs.
Requirements:
  • Hold a degree in natural sciences, e.g., chemistry, biology, pharmacy, medicine, and possess several years of experience in clinical research and clinical trial management, ideally in the field of haemato-oncology and oncology.
  • Have proven experience in at least one of the following areas, preferably in combination: Life cycle management of IMPs (from receipt to destruction), documented experience with relevant legislation and international GMP, GDP, and GCP guidelines, project and process management.
  • Previous experience in supervising, mentoring, or training colleagues and setting objectives is an advantage.
  • Exhibit exceptional understanding of processes, combining big picture risk management with attention to detail.
  • Be a problem solver, highly motivated, outgoing team player with a proven ability to take initiative, prioritize, and meet deadlines in a highly dynamic environment.
What We Offer:
  • A modern workplace in Bergisch Gladbach with opportunities for mobile work.
  • Exciting opportunities in the development of technologies with a secure future.
  • Cross-border intercultural cooperation and short communication channels.
  • A collegial corporate culture and flexible working hours enable time management on your own terms.
  • Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University.
  • Diverse corporate benefits with regard to employee health, and staff events.

We look forward to receiving your application, including your salary expectations and availability.

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