IRT System Specialist

vor 2 Wochen


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: Choose the right IRT vendor and create a study-specific contract that meets the requirements of the clinical trial.
  • Validate and Test: Conduct and document validation and user acceptance test activities to ensure the IRT system meets the required standards.
  • Maintenance and Support: Perform regular maintenance of the IRT system to adjust for trial needs and additional requirements after go-live, in collaboration with the study team.
  • Agile and Proactive Approach: Utilize an agile and proactive approach, combined with innovative technology, to solve problems and ensure the successful setup of the supply chain and patient management activities through the use of IRT.
  • Regulatory Compliance: Ensure that all work is performed according to GxP and conforms with US, EU, and other international regulations.
  • International Team Environment: Work independently and in an international, cross-cultural team environment, requiring strong communication and collaboration skills.
Requirements:
  • Master's Degree: A Master's degree in a relevant field, such as pharmaceutical sciences, computer science, or a related field.
  • Professional Experience: Several years of professional experience in a related field, with a proven track record of driving results in a changing environment.
  • Language Skills: Fluency in English, with excellent written and verbal communication skills.
  • Additional Benefits: Option of permanent employment with our business partner, extensive social benefits, including Christmas and holiday bonuses, up to 30 days of vacation per year, and free online courses, such as language courses.

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