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 a Clinical Research Manager (CRM) within the Structural Heart & Aortic Operating Unit, you will be responsible for managing the clinical research team, and managing the daily in-house activities associated with key clinical programs to support the study execution efforts. This is a people leadership role. The CRM will report to the US Clinical Research Director and independently handle various clinical study assignments, have management responsibility, and oversees and directs the work of a team of Clinical Research Specialists at all levels, from entry level to tenured.
The Structural Heart Business is one of the fastest growing businesses and helps patients all over the globe needing valve replacement.
We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. This role reports to one of the Program Leads of the Medtronic Clinical Programs for the Transcatheter Aortic Valve Replacement (TAVR) Structural Heart Therapy. This role is responsible for providing daily oversight/management of operations and execution of deliverables as well as to develop and implement strategies to enhance the capabilities and performance of the organization. To learn more about Inclusion & Diversity at Medtronic Click Here.
Location: Primary location is Mounds View, MN; would consider remote position within the United States.
Travel: up to 25% (domestic and may include international travel).
Primary Responsibilities:
Provides study management support for the conduct of clinical studies and in the development of clinical evidence for pre-market trials/studies as it applies to product lifecycle.
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.
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, employee training).
Provides management review of relevant clinical documents. Supervise training of investigators, site staff, and Medtronic clinical staff. Supervise site initiation, execution and/or closeout activities.
Oversee accuracy of clinical studies/projects.
Builds and maintains a strong network and close relationships with the various internal and external parties.
Other Responsibilities:
Accountable for execution for both local and global studies, manages clinical research projects in Structural Heart & Aortic operating unit. Responsible for conducting clinical programs consistent with applicable regulations, guidelines, and policies. Research, prepare, and revise the Investigational Plan (study protocol, Instructions For Use (IFU), report of prior Investigations, bibliography, Case Report Forms (CRFs), etc.) and other appropriate sections in consultation with the cross-functional project team, investigators, data management, and biostatistics.
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.
Develop and manage cost center budget and study budgets.
Collaborate with the cross-functional teams to coordinate clinical site activities with study needs. Provide management level representation during internal and external audits.
Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups) to drive clinical wide or cross-departmental initiatives
May oversee activities performed by Contract Research Organizations (e.g., CROs, core labs).
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.
Collaborate and/or participation on sub-teams leading process improvement initiative activities.
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
Nice to Have (Preferred Qualifications):
Advanced degree (Masters, PhD or MD) preferred. Technical degree defined as engineering, life sciences or related medical/scientific field.
Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
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
Competencies:
Leadership skills include strong communication, problem solving, 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.
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):$125,600.00 - $188,400.00
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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)
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 (http://www.medtronic.com) .
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.
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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.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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