Randstad is one of the world's leading talent companies with the
ambition to be the world's most equitable and specialized talent
company. Through our "partner for talent" corporate strategy, we find,
develop and connect specialized talents with companies - worldwide,
locally and always at a high speed. 

We are currently looking for a dedicated individual to fill the
position of IRT Specialist / IRT Experte (m/f/d) at a renowned
pharmaceutical company based in Biberach.

 

- 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

 

- Attraktives Gehalt und langfristige Jobsicherheit durch
Konzernzugehörigkeit
- Bis zu 30 Tage Urlaub pro Jahr
- Zuschuss zur betrieblichen Altersvorsorge nach Probezeitende
- Umfangreiche Sozialleistungen, inklusive Weihnachts- und
Urlaubsgeld
- Erstattung von Fahrtkosten
- In der Regel einen unbefristeten Arbeitsvertrag
- Gute Übernahmechancen bei unseren Geschäftspartnern
- Zugeschnittene Weiterbildungsmöglichkeiten und kostenlose
Sprachkurse
- Ein großes Angebot an Mitarbeitervergünstigungen