• Clinical Supply Manager

    Job Locations US-WI-Madison
    Req No.
    2018-2486
    Category
    Clinical Operations
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Clinical Supply Manager is responsible for ensuring the clinical supplies needed for all clinical studies managed by Exact Sciences are provided on time, within budget, and with good quality.  This includes management and oversight of the planning, forecasting, sourcing, packaging, labeling, distribution and return of clinical supplies

    Essential Duties and Responsibilities

    • Develop and implement clinical supply chain processes and procedures
    • Own clinical supply activities including planning, labeling, packaging, and distribution of investigational products and ancillary supplies for multiple projects
    • Forecast supply needs in conjunction with Clinical Affairs colleagues, ensuring changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered. Forecasts encompass both internally supplied materials and externally sourced items
    • Establish and document supply chain for each project as applicable to scope
    • Manage and track investigational product inventory; advises Clinical Affairs team of potential shortages and makes recommendations for resupply activities based on usage trends by performing routine forecasting/demand planning
    • Oversee investigational product shipments to ensure timely and compliant shipment and delivery to investigator sites
    • Lead management of investigational product service vendors, participate in preparation of RFP and vendor selection.  Serve as point of escalation for vendor related issues as they arise
    • Coordinate procurement and distribution of any required commercially sourced supplies
    • Collaborate with study team, sponsor, and vendors to assure proper distribution of clinical supplies to study sites
    • Develop/review/approve clinical supply packaging configurations and specifications that meet study-specific regulatory, customs, and transportation requirements
    • Plan and coordinate vendor activities for scheduling and production of labels and primary/secondary packaging of clinical supplies, including translations when required
    • Manage return and destruction of clinical supplies, with proper documentation
    • Track and follow-up on expiring product, temperature excursions and/or product complaints
    • Support transfer of Clinical suppliers to Operations Supply Chain team at commercialization
    • Coordinate with Operations Supply Chain team on forecasting, business reviews, and other vendor management activities for vendors shared across clinical and commercial products

    Qualifications

    Mandatory Skills

    • Experience interpreting clinical study protocols and developing well-planned, accurately forecasted clinical supply plans/forecasts.
    • Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives
    • Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication; ability to present in large group settings
    • Working knowledge of the clinical product development process and clinical trial methodology
    • Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities (cGMP, GCP)

     

    Preferred Qualifications

    • Experience managing clinical supply for global, in vitro diagnostic clinical studies

     

    Education and Experience

    • Bachelor’s degree or higher in health or life sciences or supply chain management
    • Minimum 5-7 years experience in the pharmaceutical/biotechnology industry performing international clinical supply/logistics management

     

    Physical Requirements

    • Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day
    • Ability to sit or stand for an extended period of time.
    • Some travel may be required

    #LI-RM1

    Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request. 

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