Clinical Research Manager- at Medtronic in Mounds View, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 29 Nov 2024

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
CLINICAL RESEARCH MANAGER - Surgical Robotics Operating Unit
In this exciting role as the Clinical Research Manager (CRM) in the Surgical Robotics Operating Unit, you will have primary focus responsibility to oversee all clinical activities related to one or more clinical studies and performing/managing the daily in-house activities associated with the studies. You will also be responsible for creating and executing business strategy and influencing internal and external customers to drive business results. This is a managerial role. The CRM will report to the Clinical Research Director and independently handle various clinical programs and clinical study assignments, have management responsibility, and oversees and directs the work of a team of Sr Clinical Research Specialists, Clinical Research Specialists, and/or Project Coordinators as required.
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.
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.

A Day in the Life
Responsibilities may include the following and other duties may be assigned.
• \tDevelops and implements clinical evidence strategies to obtain timely product approvals from worldwide regulatory bodies.
• \tMay be assigned to support new product development representing the clinical function on the Core Team
• \tProvides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.
• \tStudies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.
• \tThe 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.
• \tEnsures regulatory submissions are accurately prepared and comply with regulatory approvals.
• \tPeople working within region/country may also have the responsibilities that include:
• \tRepresents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
• \tBuilds and maintains a strong network and close relationship with the various internal and external parties.
• \tLeads execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses.
• \tProvides management review and approval of relevant clinical documents. Supervise training of investigators, site staff, and Medtronic clinical staff. Supervise site initiation activities.
• \tOversee accuracy of clinical studies/projects.
• \tEnsures 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.
• \tPerforms personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives).
• \tCollaborate with Clinical Operations department to coordinate field staff and clinical site activities with study needs. Provide management level representation during audits.
• \tInterfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, and Regulatory Affairs) to drive clinical wide or cross-departmental initiatives
• \tOversees activities performed by Contract Research Organizations (e.g. CROs, core labs).
• \tOversees the clinical department SOP/DOP review and development, employee training, and associated requirements.
• \tProvide 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.

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.


• 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.

PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM: Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

DIFFERENTIATING FACTORS

Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments.
Provides tactical and / or operational leadership and coaching.
Receives assignments in task and objective oriented terms.

Organizational Impact: Establishes operational plans and implements policies and strategies.
Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds.
May have budget or P&L accountability for a department, function or geography.
Strive for continuous improvement and consistency in deliverables.

Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes.
Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.

Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations.
Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties .
May interact on issues that have externally shared objectives.

Leadership and Talent Management: Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream.
Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments.
Authorizes hiring, firing, promotion and reward within own area.

Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. • 214.2(h)( 4)(iii)(A) and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

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

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.