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Clinical Research Specialist - Structural Heart and Aortic

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Clinical
📅
21000E2B Requisition #

Careers That Change Lives

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.

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. 

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

Travel up to 20%.

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):
To be considered for this role, the minimum requirements listed below must be evident on your resume.
  • Bachelor's degree and a minimum of 2 years of clinical research experience or advanced degree with 0 years of experience

Nice to Have (Preferred Qualifications):

  • Degree in engineering, life sciences, or related medical/scientific field.
  • CCRA certification (Certified Clinical Research Association), SOCRA.
  • Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
  • Experience in managing clinical trial data review.
  • Experience in managing multiple clinical research sites with proven results in study execution.
  • 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.
  • Clinical study management experience
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
  • 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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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)

 Travel up to 20%.

 

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 at benefits.medtronic.com

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