Senior Clinical Research Manager at Medtronic in Mounds View, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 31 Mar 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
In this exciting role as the Senior Clinical Research Manager (Sr. CRM) in the Surgical Operating Unit, you will have primary responsibility for overseeing the management, execution, and daily activities of the clinical studies in Robotic Surgical Technologies (RST) Business Unit. This managerial role reports to the Sr Director of Clinical Research for RST/DT. The Sr CRM will independently handle various clinical study assignments, have management responsibility, help support the overall clinical strategy for the business and oversee and direct the work of a team of Clinical Research Specialists.

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.
We're 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.

Location: Remote from the U.S.

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

• Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.


• Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.


• The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.


• Collaborates and implements clinical/regulatory strategies to obtain timely product approvals from worldwide regulatory bodies.


• Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.


• May be assigned to support new product development representing the clinical function on the Core 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 maintains a strong network and close relationship with the various internal and external parties.


• Leads execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses.


• Provides management review and approval of relevant clinical documents. Supervise training of investigators, site staff, and Medtronic clinical staff. Supervise site initiation activities.


• Oversee accuracy of clinical studies/projects.


• Ensures appropriate resources and priorities are maintained for the various projects assigned to their area. Oversees Clinical Research staff with all aspects of their responsibilities. May interface with regulatory agencies, as appropriate.


• Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives).


• Leads talent development, hiring, coaching


• Collaborate with Clinical Operations department to coordinate field staff and clinical site activities with study needs. Provide management level representation during audits.


• Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, and Regulatory Affairs) to drive clinical wide or cross-departmental initiatives


• Oversees activities performed by Contract Research Organizations (e.g. CROs, core labs).


• Oversees the clinical department SOP/DOP review and development, employee training, and associated requirements.


• Provide input and support for post-clinical activities and market launch of products. May co-author results of studies for medical literature and/or presentations at scientific meetings.

Must Have (Minimum Requirements):

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

• Bachelor's Degree and minimum of 7 years of clinical research experience with 5+ years of managerial experience

• An advanced degree with a minimum of 5 years of clinical research experience with 5+ years of managerial experience

Nice to Have:

• 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 direct reports and leading clinical teams. Cost-center/budget management experience.


• 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.


• Global clinical trial strategy and execution, and outcomes research study design.


• Product development experience including global clinical strategy development


• Track record and experience in hiring and developing talents

Competencies:

• Leadership skills include strong communication, problem solving, sense of urgency, high accountability, quality focus, business integration acumen, and change management.


• Demonstrated ability to work effectively globally on cross-functional teams.


• Experience in a high-demand and fast-paced environment.


• Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.


• Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.


• The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.


• Develops and implements regulatory strategies to obtain timely product approvals form worldwide regulatory bodies.


• Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.


• 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 a strong network and close relationship with the various internal and external parties.


• Leads execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses.

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):$156,800 - $235,200

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.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.