Specialist CTSM GCP Operations

London, United Kingdom;
Mainz, Germany;
Munich, Germany | full time | Job

As a Specialist in CTSM (Clinical Trial Supply Management) GCP Operations, you will play a vital role in ensuring clinical trial execution and success in compliance with Good Clinical Practice (GCP) and BioNTech standards. Your work will directly support BioNTech’s mission to develop innovative therapies by managing critical aspects of clinical supply operations. Collaborating with cross-functional teams (Clinical Operations, Regulatory Affairs, technical and clinical development teams), you will contribute to creating a seamless environment for clinical trials while maintaining high-quality standards.

Imagine yourself at the heart of global clinical studies, working alongside dedicated professionals to ensure precision and reliability in drug handling processes at clinical trial sites. Your efforts will influence department goals, setting new benchmarks for quality and efficiency in trial operations.

• Lead the cross functional development of trial-specific IMP Manuals and pharmacy questionnaires guide drug handling processes at clinical trial sites.
• Support the Manager GCP Operations in addressing IMP handling queries promptly, providing expert support to clinical teams.
• Contribute to the review of monitoring manuals and other GCP-related documents, enhancing operational precision.
• Manage complaints, deviations, changes, and quality incidents related to GCP topics effectively.
• Develops Work Instructions to ensure consistent adherence to best practices and SOPs.
• File and maintain key CTSM documents within Trial Master Files (TMF), ensuring compliance and accessibility.

• Completed university education in Pharmacy, Chemistry, Biotechnology, Biochemistry or related disciplines; vocational training in pharmacies or hospitals (e.g. Pharmacy technician) is also welcomed.
• Professional experience in hospital/pharmacy settings or clinical supply within the pharmaceutical/biotech industry (