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Stellendetails zu: Distribution Assistance (m/w/d) klinische Studien, hybrides Arbeitsmodell

Distribution Assistance (m/w/d) klinische Studien, hybrides Arbeitsmodell

Kopfbereich

Arbeit
Chemiker/in
Distribution Assistance (m/w/d) klinische Studien, hybrides Arbeitsmodell
siecon personalmanagement GmbH
Vollzeit
Biberach an der Rißab sofortunbefristetvor 30+ Tagen

Stellenbeschreibung

Vergütung: EG 8/9 zzgl. AT- Zulagen bis ab 29,71 €/Std., Gleichstellung nach BETV Chemie E11TStelle im Rahmen der Arbeitnehmerüberlassung

Für unseren Kunden, ein weltweit agierendes Pharmaunternehmen, suchen wir im Rahmen der Arbeitnehmerüberlassung ab sofort einen Distribution Assistance (m/w/d) für den Bereich klinische Studien.

Ihre Aufgaben:
• The Global CTSU Distribution Assistance is responsible to support Distribution Trial/Process Managers and IRT Trial/Process Managers for the autonomous management of the CTSU supply change within the matrix structure within the customer and external Vendor.
• Support of planning, managing and steering of timelines, costs and scope of global CTSU Distribution for agreed deliverables of global supply chain activities for assigned clinical trials, including highly complex trials (e.g. Mega trials, adaptive trial design, digital trials, trials fully outsourced to a third party (CRO)) and Investigator Initiated Studies (IIS), EAP as well as NPU programs)
• Support of the customer and Vendor meetings, minutes with action points and responsibilities
• Support of IRT and Distribution system documentation. E.g.: maintaining access user lists for IRT systems, managing super user access, creating and updating POs.
• Support of different systems like BIRDS (internal System) administration and workflows, FoCUS, EVA entries/updates, ShipSheet entries/updates, tax evaluation coordination, Elpro data base / IRT data base evaluation and KPI collection, manual release form as well as manual shipping request arranging and monitoring for bulk shipments, stability samples and sampling documentation for Investigational Medicinal Products

Ihr Profil:
• 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 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
• 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

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Arbeitsorte