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Senior Clinical Research Specialist - Cardiac Ablation Solutions (Remote within the U.S.)

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Clinical
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21000CF6 Requisition #

Careers That Change Lives

In this exciting role as the Senior Clinical Research Specialist, you will be responsible for serving as a medical/scientific consultant to clinicians, marketing teams, research project teams, development teams, and government regulatory agencies.  This role will provide support for clinical research projects through the interpretation, preparation, and communication of data from clinical investigations in preparation for device applications and/or publications from Medtronic sponsored clinical studies. 

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

Location: Remote within the U.S.
Travel up to 15% time in the field.

This role will work collaboratively with other members of the clinical team, as well as, other cross-functional partners in marketing, regulatory affairs, and physicians to support the development of clinical reports and studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. The position will establish the conditions essential for determining the safety, efficacy, medical usefulness, and/or marketability of medical device products to support the development of cardiac electrophysiology devices at all stages of the device life cycle.  Additionally, the candidate will work on a larger clinical evidence team which has the responsibility of presenting clinical data to internal and external stakeholders utilizing regulatory documents, manuscripts, and presentations.

A Day in the Life 

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

  • Oversees, designs, plans and develops clinical evaluation research studies.
  • Prepares and authors protocols and patient record forms.
  • Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
  • Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
  • Oversees and resolves 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 may prepare clinical trial budgets.
  • May be responsible for clinical supply operations, site and vendor selection.
  • People working within region/country may also have the responsibilities that include:
    • -Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
  • Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
  • Drives local evidence dissemination & awareness.

Position Responsibilities:

  • Evaluates and summarizes clinical data/evidence for clinical reports, obtaining input and alignment from key stakeholders, and develop those materials into presentations and manuscripts.
  • Provides input and support for planning pre- and post-market clinical activities, educational activities, and market launch of products.
  • Works within a larger clinical evidence team (and is a key member), with responsibilities to drive important clinical data development for novel cardiac electrophysiology devices.
  • May co-author results of studies in the medical literature and/or present at scientific meetings.
  • Interfaces with key functional areas to align the clinical study with the needs of other business areas (e.g., marketing, research, regulatory, development, patient management, and reimbursement).
  • May interface with national-level regulatory agencies including meetings, prepares, and/or conducts presentations to panel reviewers regarding requirements and results of the study.
  • Supports evidence dissemination and strategic planning for clinical projects and programs. 
  • Contributes to process development or process improvement efforts.
  • About 15% of time will be spent in the field.
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume. 
  • Bachelor’s degree required and a minimum of 4 years of clinical research experience, or advanced degree with 2 years of clinical research experience  

Nice to Have (Preferred Qualifications):

  • PhD in biology or biological sciences
  • Previous work or educational experience in cardiovascular systems
  • Clinical Research experience at Medtronic or within a medical device industry
  • Experience conducting/working on clinical trials and/or clinical studies and managing clinical trial data review
  • Experience in managing multiple clinical research sites with proven results in study execution
  • Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation and reporting
  • Experience with Clinical Operations and interfacing with CRO teams
  • Technical writing experience
  • Global perspective

 

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).
 

Travel up to 15% time in the field.

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.

Learn more about our benefits at benefits.medtronic.com

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