Mehrere IRT Specialist*in/Expert*in 4847€-7264€ plus Prämien
Location
Biberach an der Riß | Germany
Job description
STELLENBESCHREIBUNG
Mehrere IRT Specialist*in/Expert*in 4847€-7264€ plus Prämien
Standort: Biberach an der Riß
Anstellungsart(en): Vollzeit
Arbeitszeit: 37,5 Stunden pro Woche
Für unseren namhaften Kunden in Biberach suchen wir ab sofort, im Rahmen der Arbeitnehmerüberlassung, mehrere Specialist*in/Expert*in.
Aufgaben, Kompetenzen und Verantwortung:
- In your new role, you will independently lead all activities consisting of assessment, planning, conceptual realization and implementation, as well as review, maintenance and decommissionierung of study-specific IRT concepts
- You act independently as an IRT representative in cross-organizationel and cross-functional study and project teams and have deep expertise in the technical implementation of IRT concepts and clinical study design related tom 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 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
Es handelt sich bei dieser Position um ein hybrides Arbeitsmodell, welches an 2 bis 3 Tagen pro Woche aus dem Home Office abgedeckt werden kann.
Bitte beachten Sie, dass der Arbeitsort nach wie vor in Biberach ist. Bei Arbeiten vor Ort in Biberach können keine Kosten für die An- und Abreise sowie Zeitgutschriften oder Hotelübernachtungen übernommen werden
Anforderungen an die Specialist-Rolle:
- 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
- Experience in the IRT field, demonstrated in-depth knowledge of the technical aspects and functions of an IRT system (advantageous)
- Good unterstanding of the generic software development lifecycle including computer system validation of cloud systems (advantageous)
- Good unterstanding 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
- The ability to independently initiate and analyze complex tasks, taking into account applicable regulations, cost effectiveness and timelines
- Excellent communication skills and fluent in written and spoken English
Anforderungen an die Expert-Rolle:
- 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
- Experience in the IRT field, demonstrated in-depth knowledge of the technical aspects and functions of an IRT system
- Good unterstanding of the generic software development lifecycle including computer system validation of cloud systems
- Good unterstanding 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
- The ability to independently initiate and analyze complex tasks, taking into account applicable regulations, cost effectiveness and timelines
- Excellent communication skills and fluent in written and spoken English
Arbeitgeberleistungen / Unternehmensangebot
Wir bieten Ihnen:
- Persönliche Betreuung und kompetente Ansprechpartner
- Zahlung der Inflationsprämie
- Übertarifliche Vergütung
- Pünktliche Auszahlung des Lohns
- i.d.R. unbefristete Arbeitsverträge
- Bis zu 30 Tage Urlaub
- Urlaubs- und Weihnachtsgeld
- Individuelle Schulungen/Qualifikation/Weiterbildungen
- Kostenübernahme bei arbeitsmedizinischen Vorsorgeuntersuchungen
Kontaktdaten für Stellenanzeige
apero GmbH
Frau Poser
Personaldisponentin
Marktplatz 1
88400 Biberach an der Riß
Deutschland
Telefonnummer: +49 (73 51) 82 98 63 20
Faxnummer: +49 (73 51) 82 98 63 36
E-Mail: Bewerben über hokify des Personalbedarfs: Neubesetzung
Tarifvertrag: iGZ-DGB (100% nach IG Chemie)
Entgeltgruppe: E11T - E13T
Job tags
Salary