Clinical Trial Manager - IMP (m|f|d)

at  Miltenyi Biomedicine

Company Description
Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients’ lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale.
Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.
Job Description

In the Clinical Trial Execution Service department you will support our study processes and activities in line with our go-to-market strategy for investigational medicinal products (IMPs), particularly in haematological and oncological indications. You will be the expert and first point of contact for IMP-related questions of the study team and an important interface between our company and its internal groups, the IMP manufacturer and external partners (e.g. CRO).

• You will plan, coordinate and execute IMP-related trial processes and activities such as Chain of Identity (CoI) and Chain of Custody (CoC) management and requirements planning to ensure efficient and compliant supply of fresh and frozen IMP, including documentation in accordance with regulatory requirements. This includes monitoring the lifecycle of IMP and comparator products from receipt to destruction, including labelling design, packaging, IWRS (Interactive Response Technology) set-up, distribution and drug accountability.
• As the orchestration of logistics processes is critical to the product flow of our CAR-T clinical trials, you will support the implementation of IMP-related processes in collaboration with the Clinical Supply Chain department.
• You will also develop, maintain and optimise the necessary manuals and workflows for all relevant IMP processes. You will contribute to other IMP related documents as required.
• You will oversee and support the coordination of processes and tracking of out-of-specification (OoS) products during clinical trials. You will document and escalate major IMP deviations and issues to appropriate stakeholders and ensure that corrective actions are implemented and documented in a timely manner.
• Process improvement activities related to the IMP testing process will be part of your responsibilities as well as supporting the qualification, training and monitoring of the Contract Manufacturer (CMO) supplying the IMPs.

QUALIFICATIONS

• You have a degree in natural sciences, e.g. chemistry, biology, pharmacy, medicine and several years of experience in clinical research and clinical trial management, ideally in the field of haemato-oncology and oncology, e.g. in the field of cell therapies.
• You will have proven experience in at least one of the following, preferably in combination Life cycle management of IMPs (from receipt to destruction, ideally with CAR-T cells or other ATMPs), documented experience with relevant legislation and international GMP, GDP and GCP guidelines, project and process management.
• Previous experience of supervising, mentoring or training colleagues and setting objectives is an advantage.
• You will have an exceptional understanding of processes, combining big picture risk management with attention to detail.
• You are a problem solver, highly motivated, outgoing team player with a proven ability to take initiative, prioritise and meet deadlines in a highly dynamic environment.
  Additional Information

Please refer the Job description for details