At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Endoscopy operating unit improves patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies. We develop diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers. As an Endoscopy Principal Clinical Research Specialist (CRS), you will have primary responsibility in the development and execution of global clinical studies. You will lead study management duties 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. You will work with the Clinical Management, Clinical Quality, and Regulatory Affairs to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. This position assumes project management responsibilities for selected studies and site management activities as needed. This position should be able to function with minimal supervision and will provide mentorship for developing team members.

Careers That Change Lives 

The Endoscopy operating unit improves patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies. We develop diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers. As an Endoscopy Principal Clinical Research Specialist (CRS), you will have primary responsibility in the development and execution of clinical studies. You will lead study management duties 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. You will work with the Clinical Management, Clinical Quality, and Regulatory Affairs to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. This position assumes project management responsibilities for selected studies and site management activities as needed. This position should be able to function with minimal supervision.

Location:  The candidate can be based anywhere in the U.S. Travel <25%. 

A Day in the Life 

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

• Oversees, designs, plans and develops clinical research studies. May be involved in early study development including statistical design of the trial.
• Prepares and authors protocols, informed consent forms, and study plans.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Assists in overseeing and interpreting results of clinical investigations in preparation for new device or consumer application / device indication.
• 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
• Ownership in preparation of clinical study budgets, track budgets and timelines.
• Oversees clinical study operations performed by other team members, including safety, monitoring, data management, and site and vendor selection.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Escalates any study issues quickly to leadership.
• Ensures study milestones are met and mitigate timeline risks
• Maintains understanding of regulatory requirements across multiple regions.

Other Potential Responsibilities:

• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and clinical leadership.
• Reviews the status of projects and budgets; manages schedules and prepares status reports.
• Assesses project issues and develops resolutions to meet productivity, quality, and objectives.
• Develops mechanisms for monitoring project progress and for intervention and problem solving
• Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.
• Organizational Impact: May be responsible for entire projects or processes within job area.
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