IRT Specialist / IRT Expert | IRT Specialist / IRT Expert | M/W/D - Referenz 001075

consult16 GmbH

Biberach an der Riß, Baden-Württemberg, Deutschland
Published Jan 5, 2026
Full-time
Fixed-term

Job Summary

This role is for an experienced IRT Specialist or Expert to independently manage the full lifecycle of study-specific Interactive Response Technology (IRT) concepts for an international pharmaceutical company. Key responsibilities include evaluating, planning, implementing, maintaining, and decommissioning IRT systems. The specialist will act as the primary IRT representative in cross-functional project teams, applying strong technical expertise to ensure systems align with clinical study designs, compliance, and drug safety standards. A critical component of the job involves ensuring all activities strictly adhere to GMP, GCP, and international regulatory guidelines (US, EU). The ideal candidate holds a Master's degree in Natural Sciences (or equivalent extensive experience) and possesses a good understanding of the Software Development Life Cycle and Computer System Validation. This is an attractive 18-month fixed-term contract offering a hybrid work model, based in Biberach, Germany, requiring excellent communication skills and fluent English proficiency.

Required Skills

Education

Master's degree in Natural Sciences or Bachelor's degree combined with long-standing professional experience

Experience

  • Several years of experience in a related scientific field (if holding a Master's degree)
  • Long-standing experience in a related field or extensive experience in Quality Assurance (if holding a Bachelor's degree)
  • Professional experience in independently leading IRT evaluation, planning, implementation, and maintenance activities
  • Professional experience ensuring work is compliant with GMP, GCP, and international guidelines
  • Demonstrated foundational knowledge of the technical aspects and functions of an IRT system (advantageous)

Languages

English (Fluent)

Additional

  • Initial 18-month fixed-term contract; Position located in Biberach, Germany; Ability to work in a hybrid model (2-3 days remote possible, but presence required for onboarding and key appointments)