Manager CTSM IRT Systems
BioNTech
- Cambridge, MA
- Permanent
- Full-time
- 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
- 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
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 .*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!