Endologix, Inc

  • Sr. Manager, Clinical Affairs

    Job ID
    2018-1819
    Location
    US-CA-Irvine
    Category
    Clinical
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

    Responsible for developing and conducting global clinical trials/studies on Endologix products and for ensuring compliance with US Food and Drug Administration (FDA) regulations, internationally recognized standards, and other Regulatory body regulations as applicable. Directs and manages the activities of Clinical Affairs department personnel, as well as external contractors (e.g., clinical research organizations (CROs), regional monitors, and consultants). Responsible for providing accurate and complete data for peer reviewed abstracts and publications. Collaborates with internal departments and external contractors to develop strategies for podium presentations and publications.

     

    Responsibilities

    • Directs and manages the activities of Clinical Affairs staff.

    • Develop Clinical Affairs liaisons among clinical site, clinical monitoring, and internal project teams.

    • Oversee clinical management for premarket trials and post-approval studies, and registry studies, including protocol development/training, CRO management for database management/Electronic Data Capture (EDC) and bio statistical analysis, site monitoring, and timely reporting.

    • Ensures timely processing and review of clinical trial documentation including patient data, site files, safety oversight and compliance of overall trial documentation.

    • Liaison with Marketing and clinical Investigators to support the submission of abstracts and papers regarding Endologix devices for presentations at medical symposia and for publication in peer reviewed journals

    • Ability to travel up to 30% based on project needs.

    • Perform other duties as assigned by supervisor.

    Qualifications

    • Strong Leadership Ability
    • Excellent Communication Skills – communicates effectively in both written and interpersonal formats with all levels of the organization. Strong presentation and technical writing skills required.
    • Decision Making Skills – ability to exercise sound judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
    • Detail Oriented – unparalleled attention to detail and organization
    • Analytical Skills – ability to visualize, articulate, and solve both complex and uncomplicated problems and concepts and make sensible decisions based on available information
    • Consulting Skills – ability to work and partner effectively with others within the company and outside of the company.
    • Excellent Problem Solving Skills – ability to understand issues and communicate effectively with clients and team.

    Education:

    • Bachelor’s degree in a clinical, scientific, or related field required. RN or BSN degree or equivalent.
    • Advanced degree (Masters, PhD or MD) preferred.

    Experience:

    • A minimum of 8+ years of Clinical Research experience in the Medical Device Industry to include multicenter IDE clinical trials, safety surveillance, and clinical team management. (Masters may substitute for one year of experience, PhD or MD may substitute for two years of experience).

    • Experience in Cardiovascular, Vascular, and/or Class-III Devices is highly preferred.

    • Strong working knowledge of medical/scientific terminology and knowledge of International and U.S. FDA (Food & Drug Administration) regulations and GCP guidelines is required.

    • Advanced skills in Microsoft Office Suite and standard computer programs required.

     

    Specific Skills, Knowledge & Behaviors

     

     

     

    Supervisor Core Competencies:

    Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed

    Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results

    Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels

    Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level

    Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups , and looks at the company holistically

    External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products

    Continuous Improvement: Leverages best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self and team

    Problem Solving & Problem Prevention: Uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

    Accountability: Drives and focuses on results, takes initiative without direction, takes broad ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

     

    Core Competencies:

     

    Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately

    Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

    Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

    Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

    Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company

    Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

    Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self

    Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

    Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

     

    Equipment Use & Abilities Required:

     

     

    Equipment Use:  Copy machines, fax machines, calculators and personal computers and computer terminals.

    Language Skills:  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

    Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. 

     

    WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

     

    The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings.  A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.

     

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

     

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