IRT Expert | IRT Expert (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role involves leading and managing all activities related to the evaluation, planning, implementation, review, maintenance, and decommissioning of study-specific Interactive Response Technology (IRT) concepts within a global pharmaceutical company. The IRT Expert will act independently as the IRT representative in cross-functional study and project teams, leveraging expertise in technical implementation and clinical study design, particularly concerning compliance and drug safety. A key focus is ensuring all work adheres to patient safety standards, GMP, GCP, and international regulatory guidelines (US, EU). The successful candidate will utilize their knowledge of complex study designs to continuously evolve IRT concepts, keeping systems state-of-the-art, and will also support validation activities for computerized systems. This is an 18-month contract position with the possibility of permanent employment, offering a hybrid work model (2-3 days remote/home office).
Required Skills
Education
Master's degree in Natural Sciences or Bachelor's degree in a related field
Experience
- Several years of experience in a related scientific field (with Master's degree)
- Extensive experience in a related field or quality environment (with Bachelor's degree)
- Experience in the IRT field (advantageous)
- Demonstrated in-depth knowledge of technical aspects and functions of an IRT system (advantageous)
- Professional experience in applying regulatory and GMP/GCP requirements in the pharmaceutical industry
Languages
Additional
- The position is initially limited to 18 months, with an option for permanent takeover by the client. Compliance with US, EU, and other international guidelines is mandatory.
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