Snr Principal Clinical Research Specialist

Medtronic•Mounds View, MN

5d•Onsite

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. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re 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 objectives. Recognized 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 OU. 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.

Requirements

Bachelor's degree
Minimum of 10 years of clinical research experience
Or Advanced degree with 8 years of clinical research experience

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.
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 in cardiovascular 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 management skills.
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.

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.
Establishing strategic objectives.
Influencing long-range clinical and regulatory plans.
Independently driving initiatives critical to business success.
Identifying and resolving complex, cross-functional challenges.
Developing innovative solutions.
Influencing decisions that have significant impact on clinical, regulatory, and business outcomes.
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).
Influencing organizational strategy.
Leading large and complex cross-functional initiatives.
Presenting recommendations to executive leadership.
Negotiating alignment across diverse stakeholder groups.
Providing mentoring, coaching, and technical leadership to less experienced team members.
Serving as a key resource for developing clinical research talent across the organization.

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)