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.
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
• Makes improvements of processes, systems, or products to enhance performance of the job area.
• Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Exchange information of facts, statuses, ideas, and issues to achieve the business objective, and influence decision-making.

Must Have (Minimum Requirements):

• Bachelor’s degree + 4 years of relevant experience or
• Advanced degree, with 2 years relevant experience

Nice to Have (Preferred Qualifications):

• Experience with GCP, GDP, and regulatory compliance guidelines for clinical trials
• Experience with Electronic Data Capture (EDC) systems
• Experience working with an IRB
• Work experience supporting clinical research or experience in a medical/scientific area
• Education in life sciences or related medical/scientific field
• Advanced written and oral communications skills
• High attention to detail and accuracy
• Capable of working on multiple projects with ability to shift priorities & work plan based on department needs
• Proficiency in Microsoft Office/365 including Word, Excel, PowerPoint, and Outlook
• Strong prioritization, organizational, and problem-solving skills
• Ability to work independently to support team goals
• Experience working on a Global study team
• Knowledge of medical terminology
• Clinical Research experience at Medtronic or within a medical device industry
• Experience managing multiple clinical research sites with proven results in study execution
• Experience working on a global study team
• Experience in managing clinical study data review
• Basic understanding of biostatistics and study design

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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.

Salary ranges for U.S (excl. PR) locations (USD):$128,000.00 - $192,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.