• Job Description

  Req#: 152201
  
  
  
  
  
  
  
  Careers that Change Lives
  Preferred location: Mounds View, MN; open for US remote.
  
  
  In this exciting role as a Clinical Research Specialist, you will have primary focus responsibility to assist with study management duties for assigned clinical programs to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Under direct supervision, assumes project management responsibilities for selected studies and site management activities as needed.
  Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here
  A Day in the Life
  Responsibilities may include the following and other duties may be assigned.
  • Oversees, designs, plans and develops clinical evaluation research studies.
  • Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
  • Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), Good Clinical Practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
  • May be responsible for clinical supply operations, site and vendor selection.
  • Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
  • Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
  • Participates in overall clinical management plan, protocol and case report form development.
  • Assists with site initiation activities, resolution and follow-up of site issues, and study closure activities.
  • Provides support and training for clinical study sites to assure data integrity and protocol compliance. Assists in preparation of study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files.
  • Performs data review, reviews data discrepancies, generates reports. May assist with publication of study data in medical literature and/or presentation at scientific meetings
  • May interface with representatives from key functional groups including Product Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs.
  • Assists clinical management with other duties as requested.
  Must Have: Minimum Requirements
  • Bachelor's degree and 2+ years of clinical research experience (or advanced degree with 0+ years of experience)
  Nice to Have
  
  • Degree in engineering, life sciences, or related medical/scientific field.
  • Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
  • Experience in managing clinical trial data review.
  • Experience in managing multiple clinical research sites with proven results in study execution.
  • CCRA certification (Certified Clinical Research Association), SOCRA.
  • Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation and reporting.
  • Experience with Clinical Operations and interfacing with CRO teams.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
  • Excellent project management and organization skills.
  About Medtronic
  
  Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
  
  We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
  
  Physical Job Requirements
  
  The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
  A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .
  This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here .
  The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
  Additional Information
  • Posting Date: Feb 15, 2024
  • Travel: Yes, <>
  • Salary Min: $80,000
  • Salary Max: $120,000
  
  
  
  
  
  
  
  
  

• About the company

  Medtronic plc is an American-Irish registered medical device company that primarily operates in the United States.

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