Nevro Corp.

  • Director, Global Clinical Operations

    Job Locations US-CA-Redwood City
    Job Post Information* : Posted Date 1 month ago(1 month ago)
    ID
    2018-2307
    Category
    Clinical
  • About Nevro

    Nevro is a medical device company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform for the treatment of chronic pain. We started with a simple mission to help more patients suffering from chronic pain.

    At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has advanced the state of spinal cord stimulation (SCS). The Nevro® Senza® SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.

    Overview

    The Director of Global Clinical Operations will manage a team of clinical professionals and is responsible for all aspects of clinical operations, including site qualification and initiation, clinical trial agreements, patient enrollment, oversight of adverse event reporting, safety responsibilities, monitoring, adherence to protocols and determining study completion for studies conducted worldwide. The Director of Clinical Operations will also be responsible for the development of budgets, and work with management when input is necessary. Travel requirement is approximately 30%.

    Role Requirements

    • Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines, and quality standards
    • Work with the internal project team to develop protocols; amendments, CRF, informed consent form, and other documentation required for conduct of a clinical trial
    • Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
    • Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct
    • Maintain oversight and participate in the review of departmental SOPs to ensure compliance
    • Outstanding verbal and written communication skills, in addition to excellent organizational skills
    • Proven track record as a leader in clinical trials in the medical device industry; Creative, capable  problem-solver
    • Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities
    • Represent the Company externally to Investigators and trial site administrators
    • Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements
    • Travel to sites and clinical team members when necessary
    • Maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects
    • Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Nevro organization
    • Other duties as assigned

    Skills and Knowledge

    • 10+ years of management experience in a clinical research environment
    • Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
    • Experience managing clinical trial on active implantable medical devices
    • Demonstrated excellence in First in Human clinical operations activity; managing multiple global Clinical Research projects
    • Personal Leadership Skills balanced with Team Orientation
    • Outstanding Communication Skills (oral & written)

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