Clinical Trails Manager

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Company: Katalyst HealthCares and Life Sciences

Location: Neenah, WI 54956

Description:

Responsibilities:
  • You take over the responsibility for global Supply Chain activities for Investigational Medicinal Products (IMPs) of national and international clinical trials for Biological (NBE) projects.
  • In this role you act as the main point of contact to Clinical Development & Operations for assigned trials, ensuring the timely and cost efficient provision of clinical supplies.
  • With your comprehensive experience you will be the responsible leader of the CTSU trial team within the matrix structure, ensuring cross-functional collaboration and development of interfaces for all Supply Chain activities on the basis of business, regulatory and industry needs.
  • Thanks to your expertise you provide input to clinical trial protocols and bulk demands incl. comparator and non-IMP commercial products, to specific packaging designs and efficient distribution strategies.
  • Furthermore, you support investigations as Subject Matter Expert for assigned trials.
Requirements:
  • Bachelor's degree in natural sciences or similar disciplines or completed vocational training with several years' experience in clinical trials
  • Experience in working in an international environment, team leading and project management experiences as well as ability to interpret complex project requirements
  • Preferred is good knowledge and understanding of the regulatory and GMP/GCP requirements for IMPs
  • Strong problem solving capabilities with the willingness to make decisions and the ability to drive results
  • Very good communication, negotiation and presentation skills
  • bility to work independently as well as in a team
  • Fluency in written and spoken English

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