Ihre Aufgaben:

• -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.

Zusätzliche Aufgaben für die Expert-Rolle:

• You will support computerized system validation activities

Anforderungen IRT Specialist:

• 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

Anforderungen IRT Expert:

• 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

Ihre Qualifikationen:

Über Hays:

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

Bereitgestellt in Kooperation mit der Bundesagentur für Arbeit.