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Clinical
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210003QW Requisition #

Careers That Change Lives

In this exciting role as a Principal Clinical Research Program Specialist, you will have primary responsibility to support the department on critical Projects (Study) and Operations Management to enable crisp execution of global cross-functional clinical studies / projects on time and on budget. This requires partnering with team members in project planning, execution, monitoring/control, and closure as well as other aspects of Program and Operations Management.

This position is within the Global Clinical Portfolio Management Office supporting the Structural Heart and Aortic (SHA) Global Clinical Research Department. 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 

This role can be remote-based located anywhere in the U.S.

Preferred locations:  Santa Rosa, CA; Mounds View, MN

Domestic and International travel is required (approximately 25%) 

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.
  • Prepares and authors protocols and patient record forms.
  • 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 interpret results of clinical investigations in preparation for new drug device or consumer application.
  • 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.
  • People working within region/country may also have the responsibilities that include:
    • Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
    • Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
    • Drives local evidence dissemination & awareness.

Other Responsibilities:

  • Supports Program(s) in meeting goals, objectives and deliverables by providing program and portfolio leadership, and insights by analyzing and evaluating the effectiveness of complex program operations through qualitative and quantitative techniques which measure program effectiveness, efficiency and productivity, and resolve complex problems and issues.
  • Drives overall program health and consistency in processes, metrics and tools through a continuous improvement methodology.  Responsible for identifying and implementing improvements to existing processes or development of standard work.
  • Prepares materials for workflow, schedule and operational analysis, cost studies and / or resource needs and utilization. 
  • Liaison and partner with clinical program, biostatistics, publications, medical science, medical advisor, medical writing and external research teams, and vendors, to reduce risk and maintain accurate study schedules and deliverables. Lead cross-functional teams through schedule recovery.
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.

Bachelor’s degree and a minimum of 7 years of clinical research and/or program/project management/skills within the healthcare industry or advanced degree and 5 years of clinical research and/or program/project management/skills within the healthcare industry

Nice to Have (Preferred Qualifications):

  • Program/Portfolio management experience/skills within the healthcare industry (e.g., leading programs/projects within clinical research, regulatory affairs, quality, or engineering)
  • PMP certification and/or Green Belt Certification
  • Expertise in both theoretical and practical aspects of project management
  • Clinical Research experience leading clinical studies/trials at Medtronic or within a medical device industry
  • Experience as a department level business process owner, responsible for workforce management and forecasting, or financial analysis and forecasting, and/or leading process improvement/operational excellence initiatives.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.

 

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)

 

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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