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Responsibilities
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.A Day in the LifeCardiac Ablation Solutions (CAS) offers innovative cardiac mapping and ablation technologies designed to treat patients with abnormal heart rhythms (arrhythmias). CAS operates with as increasing patient volumes, complex arrhythmias, and resource constraints.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) with 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).The Principal CRS 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). 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.Must Have (Minimum Requirements):Bachelor's degreeMinimum of 7 years of clinical research experienceOr Advanced degree with 5 years of clinical research experienceNice to Have (Preferred Qualifications):Degree related medical/scientific field.Medical Device industry experienceStrong 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 withferably 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.Physical Job RequirementsThe 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
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