Validation Engineer

4 weeks ago

Ridgefield, United States SPECTRAFORCE Full time

Job Title: Trial Manager Location: Ridgefield, CT 06877 (Hybrid, 2-3 days onsite) Duration: 12 Months Pay Rate starts from $52/hr on W2 (Negotiable)

Tasks & 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. Skills: 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 Ability to work independently as well as in a team Fluency in written and spoken English Education: Bachelors' Degree

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