Careers That Change Lives

In this exciting role as a Principal Clinical Research Specialist (CRS) you will have primary responsibility in the development and execution of clinical studies and for developing and overseeing clinical strategies for effectively assessing performance related to the ongoing evaluation of product safety and effectiveness following market release. You will lead study management duties and drive processes to meet the milestones of complex clinical studies/projects for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Assumes project management responsibilities for selected studies and site management activities as needed.

This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and may be global in nature. This role works independently and under only general direction. The position provides work direction and strategic oversight of personnel supporting their trial.

The Cardiac Ablation Solutions (CAS) business is one of the fastest growing businesses and helps patients all over the globe requiring mapping and ablation for cardiac arrhythmias. The Cardiac Ablation Solutions Operating Unit focuses on Arrythmia disease management (including Atrial Fibrillation).

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

A Day in the Life

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

• Establish, develop, and foster solid relationships with Key Opinion Leaders (KOLs) and internal business partners. Partner with National Principal Investigators, clinical site investigators and physician KOLs to develop and execute publication strategies and plans.

• Lead key scientific abstract, manuscript, poster presentation, oral presentation, and late-breaking trial presentation development and submission in compliance with Medtronic SOPs and external ICMJE, GPP3, and scientific conference guidelines.

• Manage portfolio of publication activities on assigned projects (e.g. collect input on strategic alignment, drive commitment decisions, communicate decisions to investigators)

• Create and manage the project schedule for each deliverable through final delivery (e.g. peer-review publication, scientific conference presentation) while in compliance to regulatory, medical society, and corporate standards.

• Evaluate and analyze clinical data

• Own or co-own the publication plan, and serve as a subject matter expert on a variety of scientific materials

• Develop impactful publication plans and represent the Publications team in congress planning team meetings to ensure optimization of evidence distribution strategy and delivery of consistent scientific messages.

• Monitor all major scientific congresses for abstract deadlines and work with investigators of Medtronic sponsored research to drive podium presence in support of corporate scientific communication strategies and plans.

• Attend key scientific congresses and drive execution of business-related publications activities prior to, on-site, and post congresses; including management of speaker preparation and scientific session coverage and report-out.

• Serve as liaison between program management and planning, study team, and leadership

• Perform literature searches and reviews to support evidence needs and strategies

• Develop methods to track and measure impact of publications.

• Work with clinical study team(s) on data timelines to create long-term forecasting for data availability

• Oversee designs and plans, and develop clinical evaluation research studies for products that are under Clinical Investigation

• Provide work direction to a cross-functional team which includes site managers, monitoring, safety, stats, and others

• Prepare and author protocols and patient record forms

• Oversee and interpret results of clinical investigations in preparation for new device or consumer application

• Conduct registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential as needed

• Oversee and manage 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 support preparation of clinical trial budgets as needed

• Reviews status of projects and budgets; manages schedules and prepares status reports as needed

Other Responsibilities:

• Collaborate closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates

• Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives

• Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation

Must Have (Minimum Requirements):

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

• Bachelor's degree

• Minimum of 7 years of clinical research experience OR

• Advanced degree with 5 years of clinical research experience

Nice to Have (Preferred Qualifications):

• Ph.D. or MS engineering, life sciences, or related medical/scientific field

• Clinical Research experience at Medtronic or within a medical device industry

• Experience developing clinical strategies and study design

• Basic understanding of biostatistics and trial design

• Experience in Research and Development (R&D)

• Advanced presentation skills with expertise in literature identification and evaluation

• Project/program management skills/experience

• Demonstrated success in effective interpersonal and communication skills and ability to build and foster relationships with KOLs and key business stakeholders.

• Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed

• Experience in Research and Development (R&D)

• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials

• Proficient in MS Office applications: Excel, PowerPoint, Word, MS Project (or similar scheduling software), project management techniques and tools

• Expertise in both theoretical and practical aspects of project management

• PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification

About Medtronic
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.