Nevro Corp.

  • Clinical Study Manager

    Job Locations US-CA-Redwood City
    Job Post Information* : Posted Date 1 month ago(5/24/2018 3:05 PM)
    ID
    2018-2204
    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

    • Responsible for study and site management of post market observational studies; from study preparation, to site selection and activation, enrollment, maintenance and through study closure.
    • Contribute in the development and review of study protocols, patient informed consent, case report forms, clinical study material, and clinical databases in collaboration with cross functional teams.
    • Assist with investigator and site selection process, leading the qualification of study sites and on-going management of selected sites
    • Responsible for the preparation and submission of required documentation to facility and/or central Institutional Review Boards (IRBs) for study and site approval; is aware of IRB reporting requirements, ensures maintenance of IRB approval throughout the duration of the study, and ensures compliance with applicable national and international regulations
    • Negotiates budget and coordinates the execution of study agreements as a liaison between Nevro legal, clinical contracts administrator and clinical study sites
    • Develop training material and provide study training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements.
    • Oversees and resolves operational aspects of clinical studies in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
    • Ensures set up of Trial Master File (TMF) folder structures in document repositories and filing of applicable clinical study documentation in TMF for studies per standard operating procedures and study plans  
    • Maintain study management systems, study TMF and other project tracking tools
    • Interface with physicians and study support personnel      
    • Contribute in the development and completion of reporting requirements, internal reporting requirements, and clinical publications and presentations                                                                                                        
    • Performs related duties as assigned
    • This position could be home-office based for the right candidate      

     

     

    Role Requirements

    • BS; (life sciences preferred), education can be substituted with experience
    • 5-7 years related experience in supporting medical device clinical trials (preferred)

    Skills and Knowledge

    • Excellent written, oral, and interpersonal communication skills
    • Results and solution oriented
    • Demonstrated ability to make timely and well-reasoned decisions and adapt to shifting priorities and competing demands
    • Medical device experience
    • Ability to work independently and effectively on cross-functional teams
    • Ability to comply with written procedures, instructions, SOPs and other documents
    • Customer focused
    • Master’s or Advanced Degree preferred
    • Travel 30-40% 
    • Previous experience in a customer facing role
    • Ability to maintain composure and resolve conflicts with site personnel
    • Experience developing solutions for a variety of problems of varying scope & complexity
    • Demonstrated proficiency with MS Office Suite (Word, Excel and PowerPoint)
    • High attention to detail and accuracy

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