Specialist, CTSM IRT Systems

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID:9651

As a Specialist, CTSM IRT Systems, you will play a key role on the frontier of clinical trial supply management, supporting the setup and maintenance of Interactive Response Technology (IRT) systems globally for our innovative Phase I-III clinical trials. You’ll work closely with cross-functional teams and pioneering partners to ensure the seamless delivery of cutting-edge solutions, accelerating our journey from science to survival.

• Serve as a critical collaborator in communicating study parameters to IRT vendors under the guidance of the IRT Manager.
• Coordinate IRT system setup and ongoing maintenance, including User Requirement Specification (URS) reviews and User Acceptance Testing (UAT).
• Assist in preparing UAT test scripts, participating in testing activities, and identifying risks within system configurations.
• Act as a key contact for budget management and category-invoice workflows.
• Support user training through developing training materials and guiding users on system functions.
• Maintain the integrity of essential documentation by uploading materials to the electronic Trial Master File (eTMF).
• Provide basic IRT-related communication and support to vendor teams, fostering effective collaborations.

• A bachelor’s degree in one of the following fields: Computer Science, Information Systems, Life Sciences, Engineering, or a related discipline.
• Foundational professional experience minimum 3 years with exposure to clinical trial supply management or related areas in the pharmaceutical industry preferred.

• Knowledge of clinical supply chain processes and relevant GMP/GDP guidelines.
• Familiarity with IRT systems and IT-system validation/testing activities.
• Strong skills using Microsoft Office (e.g., Word, Excel, PowerPoint).
• Excellent communication skills and a proactive approach to overcoming challenges.
• Business-level fluency in English.

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.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide. 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.