We anticipate the application window for this opening will close on - 6 Dec 2024

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Careers That Change Lives

In this exciting role as a Principal 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. You will 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.

Coronary & Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic. 

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

Primary location is Mounds View, MN or Santa Rosa, CA; will consider remote position within the United States.

Travel up to 20%.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Review patient data to ensure study protocol inclusion/exclusion criteria is met and patient is appropriate candidate for therapy

• Oversees, designs, plans and develops clinical evaluation research studies

• Authors and/or reviews study reports

• 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 

• May be responsible for clinical supply operations, site and vendor selection

• Oversee study vendor deliverables

• Builds and maintains optimal relationships and effective collaborations with various internal and external parties (i.e., clinical site physicians, nurses, echocardiographers, sonographers, etc.) 

• 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

• Prepares, manages, and hosts patient screening calls for various medical devices and/or therapies

• Provides support and training for clinical study teams, physicians, and cross-functional partners 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 interface with representatives from key functional groups including Product Development, Therapy 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 must be evident on your resume. 

• Bachelor's degree

• Minimum of 7 years of cl