IRT System Specialist

vor 1 Woche


Biberach an der Riß, Baden-Württemberg, Deutschland Randstad Deutschland Vollzeit
Join Our Team as an IRT Expert

We are seeking a highly skilled IRT Expert to join our team at Randstad Deutschland. As an IRT Expert, you will play a crucial role in the development and implementation of IRT systems for clinical trials.

Key Responsibilities:
  • Develop IRT System Specifications: Collaborate with the Clinical Trial Supply Unit (CTSU) functions, Medical, Clinical Data Management, and Biostatistics to develop IRT system specifications that meet the needs of the study design.
  • Select IRT Vendor: Identify and select the most suitable IRT vendor for each study, ensuring that the chosen vendor meets the required standards and regulations.
  • Validate and Test IRT Systems: Conduct validation and user acceptance testing activities to ensure that the IRT system is functioning correctly and meets the required standards.
  • Maintain IRT Systems: Perform regular maintenance of the IRT system to adjust for trial needs, additional requirements after go-live, and other changes.
  • Utilize Agile and Proactive Approach: Employ an agile and proactive approach to solve problems and improve the IRT system, utilizing innovative technology and strategies.
  • Support Supply Chain and Patient Management: Collaborate with the study team to ensure the successful setup of the supply chain and patient management activities through the use of IRT.
  • Ensure Compliance: Ensure that all work is performed according to GxP and conforms with US, EU, and other international regulations.
  • Work in an International Team: Collaborate with an international, cross-cultural team environment, working independently and effectively.
Requirements:
  • Master's Degree: A Master's degree in a relevant field, such as computer science, mathematics, or a related field.
  • Professional Experience: Several years of professional experience in a related field, with a strong background in IRT systems and clinical trials.
  • Communication Skills: Excellent written and verbal communication skills, with the ability to discuss and present proposals in a concise and effective manner.
  • Problem-Solving Skills: Strong problem-solving capabilities, with the ability to learn new technologies and concepts to enhance operations.
  • Project Management Skills: Solid project management skills, including presenting projects and status reports to different audiences.
  • Language Skills: Fluency in English, with excellent written and verbal communication skills.
What We Offer:
  • Permanent Employment: The option of permanent employment with our business partner.
  • Extensive Social Benefits: Extensive social benefits, including Christmas and holiday bonuses.
  • Vacation Time: Up to 30 days of vacation per year.
  • Free Online Courses: Free online courses, including several language courses.

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