We anticipate the application window for this opening will close on - 7 May 2025

 

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

Prin Clinical Research Spec – Surgical Robotics Operating Unit

The Principal Clinical Research Spec is responsible for 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.  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 global nature.  This role works independently and under only general direction.  Major deliverables are reviewed to ensure clinical and business requirements are met.  The position provides work direction and strategic oversight of personnel supporting their trial and may manage a limited number of personnel, when appropriate, based on their individual career interests and Individual Development Plan.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at Medtronic Click Here

Surgical Robotics employees believe that every patient around the world deserves access to quality care and improved outcomes. Driven by our Mission, we believe that surgical robotics can add value to the healthcare ecosystem, lessen variability, and help more people around the world get better, faster.

Were making that exciting future possible — and disrupting one of the biggest and fastest growing markets in healthcare — with a game-changing portfolio of robotic and data & analytics technologies, services, and solutions. 

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.
• Develops the required clinical/project documents (e.g., Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan, CERs) in consultation with the cross-functional team, investigators, and the clinical team.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Develops study budget and manages study spending to plan.

• Critically evaluates clinical data/information and prepares interim and final reports
• 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.
• Performs risk analysis and develops contingency plans for successful study implementation.
• Ensures site activities in alignment with study milestones (i.e. startup, recruitment, closeout, etc.) and implement contingency plans, as needed
• May be responsible for clinical supply operations, site and vendor selection.
• Enlists support and provides work direction for various clinical team members to assure timely achievement of milestones and study objectives, including development of a cohesive, high-functioning team.
• 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 maitains optimal relationships and effective collaborations with various internal and external parties.
• Drives local evidence dissemination & awareness.

Qualifications

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 7 years of clinical research experience  
• Or advanced degree with a minimum of 5 years of clinical research experience  

Nice to Have (Preferred Qualifications):

• Advanced degree (Masters, PhD or MD) preferred. Technical degree defined as engineering, life sciences or related medical/scientific field.
• 7+ years’ clinical research experience at Medtronic or within a medical device industry
• Experience managing clinical research sites with proven results in study execution
• Experience in medical device clinical product trials and regulations.
• Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials

• Experience in clinical trial design, as well as managing clinical trials from start to finish. Basic understanding of biostatistics.
• Scientifically/technically adept (knowledge of product, clinical therapy, trial design, Good Clinical Practices, and global clinical regulations, including FDA and ISO regulations, ICH guidelines, for devices, biologics, and/or pharmaceuticals
• Experience facilitating committees (e.g. Clinical Events Committee, Data Safety Monitoring Board, Adverse Events Advisory Committee, etc.) and/or managing vendors (e.g. Contract Research Organizations, Core Laboratories, etc.)
• Demonstrated ability to monitor progress, identify issues, and intervene to remove obstacles, involving the appropriate decision makers
• Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
• Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
• Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills
• Willingness to accept challenging assignments and engage in relevant developmental activities
• Proficient knowledge of medical terminology
• Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
• Demonstrated ability to clearly and effectively communicate verbally and in writing
• High attention to detail and accuracy
• Exceptional project management capabilities and proficient use of project management tools

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 25%.

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):$134,400.00 - $201,600.00

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).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

 

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

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 95,000+ 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.