IRT Specialist / IRT Expert (m/w/d)

Unser Ziel ist es, Menschen zusammen zu bringen, 
die zueinander passen, um gemeinsam Aufgaben 
zu lösen.

Für unseren namhaften Kunden in Biberach suchen wir ab sofort, im Rahmen der Arbeitnehmerüberlassung einen IRT Specialist/ IRT Expert (m/w/d). Es handelt sich bei dieser Position um ein hybrides Arbeitsmodell, welches an 2 bis 3 Tagen pro Woche nach Absprache bzw. nach Bedarf aus dem Home Office/remote abgedeckt werden kann. Die Einarbeitung findet vor Ort statt.

• 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.
• 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.
• 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. 
• 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.
• Expert Role: You will support computerized system validation activities 

• 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
• Experience in the IRT field, demonstrated in-depth knowledge of the technical aspects and functions of an IRT system (advantageous)
• Good understanding of the generic software development lifecycle including computer system validation of cloud systems (advantageous)
• Good understanding of the regulatory and GMP/GCP requirements in the pharmaceutical industry and how to apply these to function is required
• Good understanding of global investigational drug activities, as well as general clinical trial execution and design
• Ability to independently initiate and analyze complex tasks, considering applicable regulations, cost-effectiveness, and timelines
• Excellent communication skills and fluent in written and spoken English

• 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
• Experience in the IRT field, demonstrated in-depth knowledge of the technical aspects and functions of an IRT system
• Good understanding of the generic software development lifecycle including computer system validation of cloud systems
• Good understanding of the regulatory and GMP/GCP requirements in the pharmaceutical industry and how to apply these to function is required
• Good understanding of global investigational drug activities, as well as general clinical trial execution and design
• Ability to independently initiate and analyze complex tasks, considering applicable regulations, cost-effectiveness, and timelines
• Excellent communication skills and fluent in written and spoken English

Wir bieten Ihnen:

• Persönliche Betreuung und kompetente Ansprechpartner
• Übertarifliche Vergütung
• Pünktliche Auszahlung des Lohns
• i.d.R. unbefristete Arbeitsverträge
• Bis zu 30 Tage Urlaub
• Urlaubs- und Weihnachtsgeld
• Individuelle Schulungen/Qualifikation/Weiterbildungen
• Kostenübernahme bei arbeitsmedizinischen Vorsorgeuntersuchungen