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 Program Manager, you will have primary focus responsibility to develop global clinical evidence generation strategies across products in alignment with Medtronic market launch and market development business needs. 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.

Location: Boulder, Colorado or Minneapolis, MN (preferred), open for remote location within the U.S..

Travel up to 25% (primarily domestic and occasionally international).

The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.

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

• Program Management: 
• Leads development and implementation of overall global clinical evidence strategy and roadmap for multiple medical device product(s) and/or remote monitoring system(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 fit-for-purpose 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 leverage 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 
  • Identifies, builds and maintains meaningful partnerships with key scientific influencers and innovators to understand clinical therapy/market needs from a clinician’s perspective 
  • Coordinates clinical evidence strategies with other cross-functions to ensure robust CRMS strategy 
• Serves as Core Team representative 
  • Provides clinical subject matter expertise (SME) and CRMS representation on various technology development (pre-PDP), product development (PDP), continued development (CDP) and remediation 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 clinical development plans to ensure timely product launch in target regions and market access and adoption 
  • Involved in changes to systems/products and what may be required to support this from a clinical perspective 
  • Keeps current on over-arching core team project priorities and deliverables 
• Plans and oversees clinical research programs from concept through completion 
• Develops and maintains detailed project plans, including timelines, budgets, resource allocations, decision logs, risks & mitigations 
• Prepares program dashboards to communicate the portfolio status, highlights, risks, mitigations  
• Present to, and partner with, clinical and medical affairs team members and leadership on the overall health of the portfolio, successes, and areas of opportunity 
• Interacts and works cross-functionally with (but not limited to) Clinical, Medical Science, Quality, Medical Safety, Regulatory Affairs, Marketing, Market Development, R&D, and regions (US and OUS) to ensure program execution to achieve business goals within regulatory requirements.  
• Ensure that clinical trials are conducted in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs 
• Clinical Study Support and Oversight: