Senior Clinical Research Specialist - Cardiac Rhythm Management (Open to Remote within US) at Medtronic in Mounds View, Minnesota

Job Description:

Careers That Change Lives

The Senior Clinical Research Specialist (Sr. CRS) facilitates the development of clinical operations through the execution of clinical projects. Conducts clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. Serves as clinical operation consultant to clinicians, marketing or research project teams, development, and government regulatory agencies. Monitors and/or interprets results of clinical investigations in preparation for new device application and/or publications. The Sr. CRS establishes the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of medical device products.

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Cardiac Rhythm Management offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.

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

Preferred Location: Mounds View, MN (Open to Remote within US)

Ability to travel 20% (domestic and international)

A Day in the Life

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

• Participates in overall clinical management plan, protocol and case report form development.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential in accordance with institutional, GCP, regulatory, and compliance requirements.
• Oversees and interpret results of clinical investigations in preparation for new 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
• Manage investigational sites
• Query management including data reviews and query resolution
• 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.
• May interface with representatives from key functional groups including Product Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs.
• Mentoring of the junior level team members
  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 required with a minimum of 4 years of clinical research experience, or advanced degree with a minimum of 2 years of clinical research experience (i.e., clinical monitoring: study start up; site management)

• Degree in engineering, life sciences, or related medical/scientific field.
• Experience/ education in Project management
• Proficient knowledge of clinical research terminology
• Clinical Research experience in the medical device industry, preferably in cardiovascular area
• Ability to work well in a dynamic, fast paced work environment
• Ability to shift priorities and work plan based on department needs
• Excellent written and verbal communication skill
• Capable of working on multiple projects in a deadline driven environment - demonstrated skill under pressure
• Solid project management skills
• Accuracy and attention to detail essential
• Successful cross functional team interaction and influencing skills
• Ability to be a self-starter and work independently to achieve on time deliverables
• Effective interpersonal skills with the ability to influence and lead others who may or may not be part of direct team.
• Results-oriented and a strong sense of urgency
• Ability to prioritize rapidly
• Strong problem-solving skills
• Excellent decision making/analysis skills
• Excellent organizational skills
• Experience in IDE/Class III medical device clinical trials preferred
• Knowledge of GCP, HIPAA, and Other Global Reporting Requirements

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

Additional Information

• Posting Date: Nov 23, 2021
• Travel: Yes, < 25 % of the Time