Expert (m/w/d)

Verstärken Sie das Team! Unser Kunde, das größte forschende Pharmaunternehmen Deutschlands in Biberach an der Riß sucht einen IRT-Specialist. Ergreifen Sie diese Job-Gelegenheit und bewerben Sie sich noch heute! Als verlässlicher Partner in Sachen Job-Suche kümmert sich Randstad um Ihre Interessen. Übrigens: Wir heißen alle Bewerber gleichermaßen willkommen, denn wir lieben Vielfalt.

• Independently leading all activities from assessment, planning, and conceptual realization to implementation, review, maintenance, and decommissioning of study-specific IRT concepts
• Acting independently as an IRT representative in cross-organizational and cross-functional study and project teams
• Ensuring that all technical implementations of IRT concepts are performed in compliance with drug safety, GMP, GCP, as well as US, EU, and other international guidelines
• Contributing to the continuous development of IRT concepts by bringing in new approaches and solutions to keep systems state-of-the-art
• Supporting computerized system validation (CSV) activities

• A Master’s degree in Natural Sciences with several years of experience in a related scientific discipline, or a Bachelor’s degree with long-term experience in a related field or Quality environment
• Demonstrated in-depth knowledge of the technical aspects and functions of an IRT system
• A good understanding of the software development lifecycle (SDLC) and regulatory GMP/GCP requirements in the pharmaceutical industry
• Experience in global investigational drug activities as well as general clinical trial execution and design
• The ability to independently initiate and analyze complex tasks while considering regulations, cost-effectiveness, and timelines
• Excellent communication skills and fluency in written and spoken English
• Wording time model: 37,5 hrs/week

• Attractive salary based on the GVP/DGB collective agreement
• Bonus for shift, Sunday and public holiday
• The possibility of partial payments
• Up to 30 days vacation per year
• Representation of interests by a comprehensive works council
• Use of the Randstad App (leave requests online, payroll viewable at any time and much more)