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Ridgefield

    Validation Engineer - Ridgefield, United States - SPECTRAFORCE

    SPECTRAFORCE
    SPECTRAFORCE Ridgefield, United States

    4 weeks ago

    SPECTRAFORCE background
    Description

    Job Title:
    Trial Manager

    Location:
    Ridgefield, CT 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

    #J-18808-Ljbffr
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