Principal Clinical Research Specialist

Medtronic • New York, NY

2d • $144,800 - $217,200 • Remote

About The Position

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 95,000 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. Medtronic’s versatile, cost-effective cardiac ablation solutions help reduce the financial burden on healthcare systems while delivering effective treatments. Medtronic’s 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. We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role In this exciting role as the 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 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 objectives. The 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 OU.

Requirements

• Bachelor's degree
• Minimum of 7 years of clinical research experience
• Or Advanced degree with 5 years of clinical research experience
• Reside within the territory and drive to multiple accounts throughout the region.
• A valid driver's license is essential for this role
• 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.

Nice To Haves

• 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.
• 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 in cardiovascular or electrophysiology therapies.
• Strong knowledge of clinical research methodologies, including study design, implementation, data analysis, evidence generation, and reporting.
• 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.
• Excellent project management, organization, and stakeholder management skills.
• Strong written and verbal communication skills, with the ability to influence and collaborate across functions and organizational levels.
• 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.

Responsibilities

• Leading the development and execution of global clinical and regulatory strategies that support the advancement of innovative ablation therapies and timely worldwide product approvals.
• Driving clinical evidence generation.
• Overseeing the design and execution of complex clinical studies.
• Ensuring compliance with applicable regulatory requirements, ethical principles, and Good Clinical Practice (GCP).
• Developing strategies and driving processes to achieve key clinical and regulatory milestones.
• Ensuring that study data, submissions, and deliverables are comprehensive, accurate, and aligned with Medtronic business objectives.
• Collaborating 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).
• Building relationships and communicating effectively with a broad range of internal and external stakeholders including investigators, key opinion leaders, regulatory authorities, and senior leaders.
• Managing the successful execution of clinical programs and the timely completion of strategic deliverables.
• Serving as a clinical research representative to local customers, investigators, and regulatory authorities, helping to inform product development, evidence generation, and regulatory strategies (for individuals supporting a specific region or country).
• 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.

Benefits

• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal