Jobbeschreibung
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)