Snr Principal Clinical Research Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

A Day in the Life

Cardiac Ablation Solutions (CAS) offers innovative cardiac mapping and ablation technologies designed to treat patients with abnormal heart rhythms (arrhythmias). As a leader in the market CAS focuses on advancing the field with cutting-edge ablation catheters cardiac mapping systems and traditional electrophysiology (EP) products.




CAS operates within Electrophysiology Therapies Operating Unit and addresses the growing challenges healthcare professionals face such as increasing patient volumes complex arrhythmias and resource constraints. Medtronics versatile cost-effective cardiac ablation solutions help reduce the financial burden on healthcare systems while delivering effective treatments.




Medtronics CAS portfolio includes a variety of catheters designed to deliver cryoablation radiofrequency ablation and pulsed field ablation energies. Our solutions are tailored to treat a wide range of arrhythmias offering single shot wide area focal and focal capabilities to ensure the best possible outcomes for patients.

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

This position will be based in Mounds View MN.

In this exciting role as the Sr. Principal Clinical Research Specialist (CRS) within the CAS Operating Unit you will be responsible for leading the development and execution of global clinical and regulatory strategies that support the advancement of innovative ablation therapies and timely worldwide product approvals. The Sr. Principal CRS is responsible for driving clinical evidence generation overseeing the design and execution of complex clinical studies and ensuring compliance with applicable regulatory requirements ethical principles and Good Clinical Practice (GCP). This role develops strategies and drives processes to achieve key clinical and regulatory milestones while ensuring that study data submissions and deliverables are comprehensive accurate and aligned with Medtronic business as a subject matter expert within the organization this individual works with a high degree of autonomy to establish strategic objectives influence long-range clinical and regulatory plans and independently drive initiatives critical to business success. The role is expected to identify and resolve complex cross-functional challenges develop innovative solutions and influence decisions that have significant impact on clinical regulatory and business outcomes.

The Sr. Principal Clinical Research Specialist will collaborate with members of the CAS leadership team and cross-functional stakeholders (e.g. Research and Development Regulatory Affairs Medical Affairs Clinical Operations Clinical Evidence Biostats Quality Marketing and other business partners). In this role you will build relationships and communicate effectively with a broad range of internal and external stakeholders including investigators key opinion leaders regulatory authorities and senior leaders while managing the successful execution of clinical programs and the timely completion of strategic deliverables. Individuals supporting a specific region or country may also serve as a clinical research representative to local customers investigators and regulatory authorities helping to inform product development evidence generation and regulatory strategies. This role has a high-level of visibility to senior leaders at Medtronic including Executive Committee members and senior leaders across the Sr. Principal CRS routinely influences organizational strategy leads large and complex cross-functional initiatives presents recommendations to executive leadership and negotiates alignment across diverse stakeholder groups. This individual also provides mentoring coaching and technical leadership to less experienced team members and serves as a key resource for developing clinical research talent across the organization.

Must Have (Minimum Requirements):

To be considered for this role the minimum requirements must be evident on your resume.

• Bachelors degree
• Minimum of 10 years of clinical research experience
• Or Advanced degree with 8 years of clinical research experience

Nice to Have (Preferred Qualifications):

• Degree in life sciences or related medical/scientific field.
• Medical Device industry experience
• Strong knowledge of electrophysiology cardiac mapping and catheter ablation technologies.
• Experience working with key opinion leaders preferably cardiac electrophysiologists.
• Demonstrated ability to independently develop and implement global clinical and regulatory strategies with long-range organizational impact.
• Experience leading clinical studies and overseeing clinical trial data review analysis and interpretation.
• Clinical Research experience at Medtronic or within the medical device industry preferably incardiovascular or electrophysiology therapies.
• Strong knowledge of clinical research methodologies including study design implementation data analysis evidence generation and reporting.
• Demonstrated ability to solve highly complex ambiguous problems and develop innovative approaches that improve processes evidence generation or business outcomes.
• Experience with Clinical Operations.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
• Experience supporting regulatory submissions and interactions with global regulatory authorities.
• Demonstrated ability to develop and execute clinical evidence strategies that support product development regulatory and business objectives.
• Proven experience leading large complex cross-functional initiatives and aligning diverse stakeholders to achieve strategic objectives.
• Excellent project management organization and stakeholder managementskills.
• Experience influencing executive leadership decisions through effective communication negotiation and presentation of complex clinical and regulatory information.
• Strong written and verbal communication skills with the ability to influence and collaborate across functions and organizational levels.
• Experience mentoring coaching and developing clinical research professionals and leading through influence in a matrixed environment.

For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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.

Salary ranges for U.S (excl. PR) locations (USD):$175200.00 - $262800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insurance Health Savings Account Healthcare Flexible Spending Account Life insurance Long-term disability leave Dependent daycare spending account Tuition assistance/reimbursement and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans 401(k) plan plus employer contribution and match Short-term disability Paid time off Paid holidays Employee Stock Purchase Plan Employee Assistance Program Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) and Capital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Required Experience:

Staff IC