C. R. Bard, Inc.

  • Associate Post-Market Clinical Study Specialist

    Posted Date 2 weeks ago(11/29/2018 5:45 PM)
    Job ID
    Career Level
    entry level
  • Overview

    Bard has joined BD, together advancing the world of health.  BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Associate Post-Market Clinical Study Specialist located in Covington, GA.

    Summary of Position with General Responsibilities

    The Associate Post-Market Clinical Study Specialist will manage clinical data collection efforts in the development and execution of strategies to obtain information and support concerning medical devices requiring clinical data for the purpose of facilitating worldwide registration. The specialist will assist in authoring post-market clinical follow up (PMCF) plans, executing PMCF activities, analyzing data collected, and summarizing in evaluation reports. The specialist will ensure compliance with federal and applicable regulatory agency requirements, and SOPs. The Specialist drives value by performing/coordinating activities, information, and tools to produce excellent results aligned with project goals and milestones.


    The Specialist may work independently or as part of a larger team in the execution of assigned projects.

    Essential Job Functions

    This position includes the following duties and responsibilities.  Other duties may be assigned.


    • Coordinates, assists in, or leads the development and execution of study- or project-related deliverables, including but not limited to, project and operational plans, status reports, and other project-related documents.


    • Conducts Post Market Clinical Follow-Up projects / studies according to sponsor protocols, including but not limited to, start-up activities, site selection, initiation, interim monitoring and close-out;


    • Tracks project spending and provide financial updates as requested.


    • Collaborate with Quality, Clinical, Regulatory, Marketing and other cross-functional partners to provide input to the Post-Market Clinical Program.


    • Ensure compliance with Bard/BD standards, policies and procedures, Good Clinical Practice, and local, regional, and federal regulations.


    • Develops and maintain therapeutic and device operation knowledge literature required to support identified products and related clinical studies, stays informed about applicable clinical landscapes and trends; apply this knowledge to the development of well-written, clear and concise reports.


    • Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities.


    • Participate in work streams and or process improvement initiatives.

    Basic Qualifications

    • Able to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, EU MDR, etc.) as needed.


    • Basic understanding of statistics and statistical methods.


    • Able to coordinate and lead multiple projects simultaneously in a fast-paced work environment.


    • Demonstrates initiative, is decisive, guides and motivates others.


    • Able to identify problems and root causes and propose potential solutions and initiate action independently.


    • Strongly motivated, is able to achieve work goals, and executes through formal channels.


    • Demonstrable proficiency with the Microsoft suite of applications (Access, Excel, Internet Explorer, Outlook, PowerPoint, Project, SharePoint, Word)

    Education and/or Experience

    o   A minimum of a B.S. degree in a health science or related field, preferably with a focus on clinical research, operations, technology, and/or project management is required.    Graduate degree in Epidemiology/Public Health or Clinical Research is preferred.


    o   Minimum 2 years relevant experience in medical device/drug clinical research.


    o   Strong medical, technical or clinical background required.  Strong command of medical and surgical terminology.


    o   Effective written, verbal and presentation skills in the area of technical/clinical applications. 

    Physical Demands

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear.  The employee will sometimes be required to move around in manufacturing facility or meet with medical professionals in a hospital environment.  Specific vision abilities required by this job include close vision and color vision.


    Employee is required to meet with other personnel in other areas of the building.

    Work Environment

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    This position is in an office environment.


    No special work environment conditions other than minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings.

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