Clinical Trial Administrator is responsible to support Trial Managers for the autonomous management of the CTSU trial team within the matrix structure
Support of planning, managing and steering of timelines, costs and scope of Trial Teams 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 team meetings, minutes with action points and responsibilities
Support of CTS preparation documentation
Support of different systems like BIRDS (BI System) administration and workflows, FoCUS entries/ updates, CES entries/updates, AC Evaluation coordination, AC Ordering, MLT drafting prior to TrM review/ approval, GTL maintenance, manuel release form as well as manuel shipping request for bulk shipments, stability samples and sampling documentation for Investigational Medicinal Products
Ihre Qualifikationen:
Bachelor’s-Degree with some years of relevant experience
Willingness to work onsite in the area of Ulm
Experience in Pharmaceutical industry
Project management skills
Broad and thorough knowledge and understanding of applicable US and EU regulations and other international regulations
Demonstrates problem solving capabilities and encourages the implementation of innovative approaches, new technologies and strategies to support the successful completion of supply chain activities
Ability to drive results in a changing environment and to discuss and present proposals in a concise and effective manner
Demonstrated ability to present projects or status reports to different audiences
Computer skills e.g. Microsoft Office 365, Project Management Software