We anticipate the application window for this opening will close on - 16 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

In this exciting role as a Senior Clinical Research Specialist (CRS) within the Structural Heart and Aortic Operating Unit, you will have primary focus responsibility to lead 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. This work will drive development and advancement of best-in-class Aortic therapies.  Senior CRS will work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies and assume project management responsibilities for selected studies and site management activities as needed.

The Senior CRS will collaborate with other members of the Structural Heart and Aortic Clinical Research and Medical Science Team, as well as other cross-functional stakeholders (e.g., Research and Development, Corporate Biostats, Regulatory Affairs, Clinical IT, and others). The Senior CRS collaborates, build relationships, and communicates effectively with a large group of internal and external stakeholders in a rapidly changing landscape, while managing the timely completion of deliverables.

The Structural Heart and Aortic integrated operating unit offer 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.  This role will be within the Aortic therapies clinical research group. 

You’ll always have new challenges pursuing ideas that are exciting, innovative, and just plain cool. Build out the future of Aortic therapies. Think critically about healthcare problems and/or opportunities to advance science faster than others. Do research on improving the healthcare of millions.

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 Santa Rosa, CA, but open to consider remote position within the United States.

Ability to travel up to 10% domestic and international.

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.

• Experience with FDA and MDR regulations

• 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.

• Manages and able to work effectively in an ambiguous environment where not all inputs/outputs have clear definition and responsibilities. 

• 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.

• Oversees 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. Prepares 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