We are currently looking for a dedicated individual to fill the position of IRT Specialist / IRT Experte (m/f/d) at a renowned pharmaceutical company based in Biberach.
Here's what we offer
1. Attractive salary and long-term job security through group affiliation
2. Up to 30 days vacation per year
3. Contribution to company pension scheme after end of probationary period
4. Extensive social benefits, including Christmas and vacation bonuses
5. Reimbursement of travel expenses
6. Generally an open-ended employment contract
7. Good chances of being taken on by our business partners
8. Tailored further training opportunities and free language courses
9. A wide range of employee benefits
Your tasks
10. In your new role, you will independently lead all activities consisting of assessment, planning, conceptual realization and implementation, as well as review, maintenance and decommissioning of study-specific IRT concepts.
11. You act independently as an IRT representative in cross-organizational and cross-functional study and project teams and have deep expertise in the technical implementation of IRT concepts and clinical study design related to compliance and drug safety.
12. You will also contribute to the continuous development of IRT concepts by bringing in new approaches and solutions to keep systems state of the art.
13. You will ensure that all work is performed with patient safety in mind and in compliance with GMP and GCP as well as US, EU and other international guidelines.
Additional tasks for the Expert role:
14. You will support computerized system validation activities
Your profile
Requirements IRT Specialist:
15. Master's Degree in Natural Sciences and several years experiences in a related scientific discipline or Bachelor's Degree with long term experience in a related field or experience in Quality
environment
16. Experience in the IRT field, demonstrated in-depth knowledge of the technical aspects and functions of an IRT system (advantageous)
17. Good understanding of the generic software development lifecycle including computer system validation of cloud systems (advantageous)
18. Good understanding of the regulatory and GMP/GCP requirements in the pharmaceutical industry and how to apply these to function is required
19. Good understanding of global investigational drug activities, as well as general clinical trial execution and design
20. Ability to independently initiate and analyze complex tasks, considering applicable regulations, cost-effectiveness, and timelines
21. Excellent communication skills and fluent in written and spoken English
Requirements IRT Expert:
22. Master's Degree in Natural Sciences and several years experiences in a related scientific discipline or Bachelor's Degree with long term experience in a related field or significant experience in Quality environment
23. Experience in the IRT field, demonstrated in-depth knowledge of the technical aspects and functions of an IRT system
24. Good understanding of the generic software development lifecycle including computer system validation of cloud systems
25. Good understanding of the regulatory and GMP/GCP requirements in the pharmaceutical industry and how to apply these to function is required
26. Good understanding of global investigational drug activities, as well as general clinical trial execution and design
27. Ability to independently initiate and analyze complex tasks, considering applicable regulations, cost-effectiveness, and timelines
28. Excellent communication skills and fluent in written and spoken English