IMP Manager - Clinical Trials mfd
IMP Manager - Clinical Trials mfd
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Salary Not Disclosed
1 Vacancy
Job Description
In the Clinical Trial Execution Service department you will support our study processes and activities in line with our gotomarket strategy for investigational medicinal products (IMPs) particularly in haematological and oncological indications. You will be the expert and first point of contact for IMPrelated 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 IMPrelated 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) setup distribution and drug accountability.
- As the orchestration of logistics processes is critical to the product flow of our CART clinical trials you will support the implementation of IMPrelated 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 outofspecification (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 haematooncology 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 CART 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
