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Clinical
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19000EKK Requisition #
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Location: Open for remote location.  Preferred location, Mounds View, MN or Santa Rosa, CA.

 
Careers That Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

 

This position will support the Clinical Portfolio management of the CSH Global Clinical department. The candidate will manage a group of project managers that lead and direct one or more Clinical Operations initiatives that span across multi-functional groups. The selected candidate will develop and execute projects on schedule, within budget while ensuring that they meet the scope of the assignment. The candidate will be responsible to identify appropriate technical and business resources needed for their direct team and contribute to the larger operations team. In addition, the candidate must keep current on advances in the field of Information Technology/Business Intelligence in order to provide technical, and analytical guidance to project teams. This position will consult on services strategy in addition to planning, developing and implementing efforts that support and promote the CSH Clinical Affairs Department. 

 
CVG
Cardiac and Vascular Group (CVG)

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This group includes Aortic, Peripheral and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), Atrial Fibrillation (AF) Solutions, and Coronary and Structural Heart products.

 

Within CVG, Coronary and Structural Heart provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

 
 
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. 
Other Responsibilities:
  • Provide Project leadership and portfolio analysis to Clinical Department.
  • Responsible for identifying and delivering process improvement opportunities.
  • Create emphasis on programs and cross-program information.
  • Key focus on program management development- process; metrics and tools etc.
  • Clinical Study governance.
  • Develop, Manage and execute to Operations team objectives
  • Must possess the ability to plan, develop and deliver effective written communications to a broad, global and diverse customer base in a professional and strategic manner.
  • Experience leading and managing various projects (on time) that involve resources and tasks across multiple teams using Project Management tools.
  • Demonstrated ability to work in a matrix and remote management structure.
  • Experience working in a Clinical department.
  • Prior experience with change management.
  • Demonstrated problem analysis and solution recommendation capabilities.
  • Demonstrated practical skills with successful project management initiatives.
  • Strong interpersonal and influence management skills.
  • Ability to work with all levels of management.
  • Outstanding verbal communications in both formal and informal settings.

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 7 years of clinical research or clinical operations experience with 5+ years of managerial experience or advanced degree and a minimum of 5 years of clinical research or clinical operations experience with 5+ years of managerial experience

 

Nice to Have (Preferred Qualifications):

  • Project Management Certification (preferably PMI)
  • Green Belt or above certification
  • 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).
  • Proficient in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
  • Strong presentation skills, both delivery and development
  • Expertise in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
  • Demonstrated success in previously working in cross functionally in a matrixed organization
 

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 Domestically and Internationally is required (approximately 25-40%).


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