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 Clinical Trial Coordination 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, your role will support the Clinical Trial Lab Management in the operational daily business.

• Create and maintain trial related lab trackers (e.g. on screening samples, lab reconciliation tracker, sample destruction, etc.) as required and provide relevant overview / information to applicable trial team members (e.g. Lab Manager, Clinical Trial Manager) ensuring, the tracking requirements are met.
• Check relevant Requisition forms/ kit orders by clinical sites for correctness, as required and check if sites at all/ relevant times have sufficient material.
• Perform reconciliations and QC checks for lab topics (e.g. on lab samples), and document/escalate issues to Lab Managers.
• Organize regular lab shipments to third party labs and perform sample selection based on defined criteria.
• Ensure filing of relevant lab related documents (e.g. requisition forms, result reports) and trackers in the Trial Master File
• Support creation and adaption of lab management related documents such as Memos, NTFs, workflows and of lab management related SOPs.
• Provide additional support to Lab Managers, for activities and interface with CRO, labs, vendors, clinical sites and any other internal or external partners in the lab related operational study conduct, as needed.

QUALIFICATIONS

• Education in a Laboratory field, (BTA, Lab assistent or technician) or in a medicinal-pharmaceutical field (health care, nursing, medical technical assistant, assistant physical technician, medical documentation or other) or BSc. in biology, biochemistry, or relevant scientific education.
• Attention to detail and high organization come naturally to you. You are accustomed to prioritizing multiple tasks, taking initiative, working independently, and achieving project deadlines.
• As a motivated and open-minded team player with well-developed interpersonal abilities, you enjoy working in a dynamic environment.
• You are naturally communicative and have effective communication (verbal and written) and organization skills, both in English and German.
• Your proficiency in MS Office is also expected.
  Additional Information

• Create and maintain trial related lab trackers (e.g. on screening samples, lab reconciliation tracker, sample destruction, etc.) as required and provide relevant overview / information to applicable trial team members (e.g. Lab Manager, Clinical Trial Manager) ensuring, the tracking requirements are met.
• Check relevant Requisition forms/ kit orders by clinical sites for correctness, as required and check if sites at all/ relevant times have sufficient material.
• Perform reconciliations and QC checks for lab topics (e.g. on lab samples), and document/escalate issues to Lab Managers.
• Organize regular lab shipments to third party labs and perform sample selection based on defined criteria.
• Ensure filing of relevant lab related documents (e.g. requisition forms, result reports) and trackers in the Trial Master File
• Support creation and adaption of lab management related documents such as Memos, NTFs, workflows and of lab management related SOPs.
• Provide additional support to Lab Managers, for activities and interface with CRO, labs, vendors, clinical sites and any other internal or external partners in the lab related operational study conduct, as needed