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Clinical
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19000FIL Requisition #
Location:  Minneapolis, MN / open for remote location
 

Careers That Change Lives

In this exciting role as a Clinical Research Manager (CRM), you will have primary responsibility for the oversight and performance of a portfolio of post market surveillance studies that are being performed in the Post Approval Clinical Surveillance (PACS)group on behalf of Medtronic business units.


The CRM works cross functionally with business units, functional stakeholders and leaders to develop a data collection strategy for the surveillance of Medtronic products.  The CRM oversees the studies, processes/procedures, and staff that perform the steps required to collect post market surveillance data on Medtronic products including oversight of site initiation, training, compliance to requirements, general ongoing participation of sites for data collection, as well as processes and procedures related to PACS infrastructure.  The CRM may lead a team of Clinical Research Specialists who maintain site relationships, ensure site compliance and complete ongoing site management tasks to ensure study health in compliance with global regulations and Medtronic procedures.

 
Come for a job, stay for a career.

The Post Approval Clinical Surveillance team is recognized as an enterprise leader for cost effective global post market clinical surveillance methodologies and strategies to guide the generation of world class evidence and fulfill the Medtronic Mission.  Current evidence needs have created increased need to report clinical data and the group is experiencing significant growth.


A Day in the Life

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.
Must Have (Minimum Requirements):

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

 

Bachelor’s degree and a minimum of 5 years of experience managing/leading people, teams, and/or projects in clinical research, or advanced degree with a minimum of 3 years of experience managing/leading people, teams, and/or projects in clinical research

 

Nice to Have (Preferred Qualifications):

  • 5+ years as manager with project oversight and/or project management lead (people management experience or experience leading teams)
  • Internal to Medtronic strongly preferred (clinical research management or project/program management lead experience at Medtronic or experience with Medical Device and/or combination product trials and regulations).
  • Experience with medical writing
  • Familiarity with EU MDR regulations
  • Interest and experience with the quality function
  • Clinical Research/study management experience
  • PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification
  • Cost-center/budget management experience.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
  • Experience in managing clinical trial data review.
  • Ability to incorporate and adhere to good clinical practices and regulatory standards.
  • Ability to manage multiple clinical research sites with proven results in study execution.
  • Ability to identify and implement solutions in addressing study issues.
  • Basic understanding of biostatistics and trial design.
  • Demonstrated ability to work effectively on cross-functional teams. 
  • Willingness to accept challenging assignments and engage in relevant development activities.
  • Experience in resource and expense management.
 

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)

 
Ability to travel up to 20%.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
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