In this exciting role as a Senior Clinical Research Specialist (CRS) for the in the Gastrointestinal & Hepatology (GIH) division of the Respiratory, Gastrointestinal & Informatics (RGI) global business unit, you will have primary focus responsibility for overseeing and executing clinical research studies. The Sr CRS is responsible for clinical study management, developing strategies and driving processes to meet the milestones of complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. The Sr CRS sets work direction for the study team and owns the study data to ensure that all data collected is comprehensive, accurate, and up to date.

The Gastrointestinal & Hepatology (GIH) division of the RGI business unit develops diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers.

This is a remote based role so the candidate can live anywhere in the US.

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.

• Oversees, designs, plans and develops clinical evaluation research studies. May be involved in early study development including statistical design of the clinical study
• Prepares and authors protocols and case report 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 or expanded clinical devices.
• Oversees and resolves operational aspects of clinical studies in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations.
• May develop and manage clinical study 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.
• Clinical Study management: study start up, monitoring, site management and qualification

Must Have (Minimum Requirements):

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

• Bachelor's degree required and a minimum of 4 years of clinical research (i.e., Clinical Study management: study start up, monitoring, site management and qualification) experience, or advanced degree with 2 years of experience (i.e., Clinical Study management: study start up, monitoring, site management and qualification)

• Clinical Research experience at Medtronic or within a medical device industry highly preferred.
• Degree in engineering, life sciences, or related medical/scientific field.
• Sponsor Research and Investigator-initiated research within medical device industry, a multicentered investigator-sponsored management experience: NIH or Academic Research (Universities).
• At least 2 years' experience in direct management of studies of medical devices: implantables or a list of classes i.e. Class I to III. Nonsignificant risk or significant risk ( NSR or SR). Pivotal or novel clinical studies.
• Corporate or Competitor environment with studies that run under FDA 812, ISO 14155 or GCPs.
• Experience working on a global study team. Ability to manage multiple clinical research sites with proven results in study execution.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical studies.
• Experience in managing clinical study data review.

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 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 approximately 25%

Check out benefits.medtronic.com

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 here .

This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .

Salary Min: $99,200 Salary Max: $148,800

Additional Information

• Posting Date: Jan 3, 2021
• Travel: Yes, < 25 % of the Time