Clinical Research Specialist at Medtronic in Mounds View, Minnesota

Job Description:

Looking for a new and exciting opportunity working with trial data and leading projects to streamline work across a business unit? Join Medtronic Structural Heart and Aortic team that works with mitral and tricuspid team creating superior therapies for patients with mitral and tricuspid valve disease.

Careers that Change Lives

We are looking for a passionate, high-energy, strategic-minded, self-motivate individual with a back ground in trial management/coordinating who will drive ideas and projects forward in support of the SH&A operating unit strategy. In this role you will collaborate with Site managers and trial leads (Clinical), Project Management Office, Therapy Development, R&D, Regulatory, and other cross functional partners.

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 mitral and tricuspid clinical group.

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; will consider remote position within the United States. Travel up to 10%.

A Day in the Life
Responsibilities may include the following and other duties may be assigned.

• Tracking study activities across multiple therapies. Leveraging Smartsheet, CTMS, EDCs, excel and other trial systems for an overarching view of study health.
• Building reports to track compliance and study activity using Power BI
• Working with cross functional partners to understand current workflow, identify opportunities for efficiency and implement strategies across therapies.
• Draft and implement job aides
• Reports on progress and results of clinical investigations
• Create, support and implement study enrollment initiatives
• 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.
• 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.
• Coordinates activities of associates (assigned clinical staff) and investigators to ensure compliance with CIP and overall clinical objectives
• Assists clinical management with other duties as requested.
• 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.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of clinical research experience, or advanced degree with 0 years of experience

• Degree in life sciences, or related medical/scientific field.
• Experience conducting/working on clinical studies and managing clinical trial data review
• Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
• Experience with Power BI
• Experience with Smartsheet
• CCRA certification (Certified Clinical Research Association) or SOCRA.
• Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation, and reporting.
• Excellent project management and organization skills.
• Experience with Clinical Operations.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.

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) here .

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).