Clinical Research Program Manager - Endovenous at Medtronic in Minneapolis, Minnesota

Job Description:

Careers That Change Lives

In this exciting role as a Clinical Research Program Manager, you will have primary responsibility to develop novel Clinical research strategies within the Endovenous business, with a particular focus on Alternative Data Sources. The CRPM will consider how to leverage existing or new Clinical evidence to bring new products to market, indication expansion efforts for existing products, and serving as the Clinical team member to support due diligence efforts. You will represent the Clinical function on the core team(s) and work as a strategic partner cross-functionally. You will be involved with evidence dissemination efforts (helping with market launch and market development business needs), and be the primary point of contact and owner for any physician sponsored research proposals (ERPs). You will act as the Clinical Subject Matter Expert for a subset of products in the Endovenous space, and you will engage and manage relationships with R&D, Medical Affairs, Marketing, Market Development, global business partners, and other internal and external cross-functional partners to satisfy program needs.

We're a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Clinical Research and help shape policies that change lives.

We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader - that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients.

To learn more about Inclusion & Diversity at Medtronic Click Here

Remote; preferred location: Minneapolis, MN

A Day in the Life

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

• Interacts and works cross-functionally with other departments, including but not limited to Clinical, Medical Science, Quality, Medical Safety, Regulatory Affairs, Marketing, R&D, and regions (US and OUS) to ensure program execution to achieve business goals within regulatory requirements.
• Directs day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple functional organizations.
• Drive the global publication and evidence dissemination strategy of high priority programs through close collaborations with Medical Affairs, healthcare economics, global portfolio and marketing functions.
• Identifies, builds and maintains meaningful partnerships with key scientific influencers and innovators to understand clinical therapy/market needs from a clinician's perspective
• Leads development and implementation of overall clinical evidence strategy and roadmap for multiple medical device product(s):
  
  
  • Defining clinical evidence needs for current (released product) and new product portfolios
  • Collaborates with key internal and external global stakeholders to identify evidence gaps
  • Executes a strategy to acquire the necessary data to support the desired objectives, including identifying the level of clinical evidence required to satisfy identified business objectives
  • Identifies and leverages innovative real-world data and real-world evidence opportunities to fulfill evidence requirements optimizing time and costs
  • Leverages latest literature, regulations and guidance to build and execute on evidence strategies
  • Financial budget modeling and scenario planning around evidence needs
  • Coordination of clinical evidence strategies with other functions to ensure robust Medical Affairs strategy
  
  
• Clinical Program Management
  
  
  • Core Team representative
    
    
    • Provides clinical subject matter expertise (SME) on various product development (PDP) projects
    • Leverages competitive intelligence around clinical/regulatory pathways, indications and labeling, claims, clinical evidence to inform and execute on differentiated and market leading evidence that support business stakeholders
    • Determines burden of evidence for our products and partners with core team stakeholders to develop innovative and novel clinical development plans to ensure timely product launch in target regions
    
    
  • Study Oversight:
    
    
    • Provides input, as appropriate, into clinical investigation documents to ensure alignment with overall business strategy
    • Oversees and interprets results of clinical investigations in preparation for new device or supporting application
    • Works with statistical team on analysis of data from MDT-internal and external databases, as appropriate
    • Advocates for appropriate support and funding for highest priority projects, in conjunction with cross-functional evidence team
    
    
  • Regulatory support, including EU MDR Requirements:
    
    
    • Provides input and reviews, as appropriate, clinical evaluation documents to ensure alignment with overall product MDR strategy, including: Clinical Evidence Plan (CEP), PMCF plan, PMCF report, Clinical Evaluation Report (CER)
    • Risk management file and IFU development
    • Supports regulatory submissions as needed (e.g., FDA pre-submissions, IDE, 510k, PMA)
    
    
  
  

This position requires a strong background in creating and executing business strategy, and influencing internal and external customers to drive business results. This position requires innovative thinking with respect to program strategy and project management for the clinical program(s), evaluating the safety and effectiveness of new products and / or modifications to existing products. This work is accomplished with minimal oversight and has significant impact to the business. Many programs are global and will require an understanding of the worldwide landscape.

Must Have (Minimum Requirements):

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

Bachelor's degree required with a minimum of 5 years of experience in clinical research program/project management and/or clinical strategy or advanced degree with a minimum of 3 years of experience in clinical research program/project management and/or clinical strategy

Nice to Have (Preferred Qualifications):

• Advanced degree in Engineering, life sciences, or related medical/scientific field.
• Experience developing Clinical study strategies
• Clinical Research experience at Medtronic or within a medical device industry.
• Demonstrated clinical acumen across the care continuum and working with clinicians (e.g., start-up /feasibility studies, IDE studies, post-market studies)
• Excellent program/project management and organizational skills.
• Experience working on a Global study team
• Experience in managing clinical trial data review and multiple clinical research sites with proven results in study execution
• Comprehension and understanding of Clinical affairs functional systems and processes
• Working knowledge of FDA and key International regulations
• Basic understanding of biostatistics and trial design
• Thrives in a dynamic environment and flexibility to adapt to changing priorities
• Proficient experience using Microsoft Word, Power Point, and Excel

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 30% domestically and internationally.

Check out benefits.medtronic.com

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.

Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .

Additional Information

• Posting Date: Jan 20, 2021
• Travel: Yes, < 25 % of the Time

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