Manager CTSM IRT Systems
Open for hire at one of the following locations – Cambridge Erie Street. - Job ID: 7280
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Manager CTSM IRT Systems
Responsibilities
• Identifies study supply parameters with input from IMPM
• Coordinates communication of study parameters to the IRT vendor
• Coordinates IRT system setup and maintenance (User Requirement Specs review, User Acceptance Testing)
• Prepares and reviews UAT test script
• Coordinates UAT testing and identifies risks in configuration
• Consolidates feedback and coordinate assessment of risks identified during testing
• Uploads completed IRT User Requirement Specification and UAT testing to eTMF
• Develops training material for IRT
• Drives performance management with vendor (e.g., KPIs and debugging)
• Key contact to IRT vendor
• Supports and trains users on IRT system usage
Qualifications
• Relevant professional experience (usually +3 years) with IRT systems in Clinical Trial in Pharmaceutical or Biotech or any other equivalent industry setting
• Deep knowledge about IT-System Validation Activities
• Deep understanding of patient randomization strategies and potential impact on clinical supply wastage/optimization
• Deep Knowledge about IRT systems and standard office software proficiency (e.g., MS Office)
• Significant experience across multiple study designs/types in optimization of clinical supply chain, through use of IRT technology.
• Working knowledge of clinical supply chain and associated GMP/GDP activities
• Ability to read and understand clinical protocols and translate requirements for IRT system needs
• Ability to develop training materials and conduct trainings
• Business-professional English language skills
Benefits for you
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.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Cambridge Erie Street. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!