Specialist CTSM GCP Operations
London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID: 10680
About the Role:
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.
Your Contribution:
- Lead the crossfunctional 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.
A Good Match:
- 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 (<3 years preferred).
- Knowledge of IMP mManuals, pharmacy /questionnaires and medical writing skills.
- Comprehensive understanding of GCP principles (e.g., ethical considerations, adequate drug information).
- Familiarity with global clinical trial supply up to Phase III.
- Proficiency in TMF management and electronic filing systems.
- Strong command of standard office tools like MS Office and business-professional English language skills.
- Excellent communication skills coupled with curiosity and openness to learn new topics.
- Reliable problem-solving abilities with a diligent approach to complex tasks.
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.