Job Title: Clinical Research Manager (CRM) - Structural Heart & Aortic Operating Unit
Location: Primary: Mounds View, MN | Remote (U.S. Locations)
Travel: Up to 25% (domestic and international)
At Medtronic, we are on a mission to alleviate pain, restore health, and extend life. As a global leader in healthcare technology, we are solving the world’s most challenging health problems with cutting-edge solutions. Join us and be part of an innovative team that is dedicated to improving healthcare access and equity for all. This role offers an opportunity to grow your career while contributing to the development of life-changing therapies in the Structural Heart & Aortic Operating Unit.
As a Clinical Research Manager (CRM) in the Structural Heart & Aortic Operating Unit, you will lead a team of Clinical Research Specialists and oversee clinical research activities for key clinical programs, particularly in the Transcatheter Aortic Valve Replacement (TAVR) therapy area. You will report to the US Clinical Research Director and ensure the successful execution of clinical studies, providing leadership, strategic direction, and support for study management efforts.
This role requires a strong focus on people leadership, clinical trial oversight, and a deep understanding of regulatory requirements. You will manage resources, guide the team in executing clinical research programs, and work closely with cross-functional partners to enhance organizational performance.
Clinical Study Management:
Oversee the execution of clinical studies across local and global sites, ensuring compliance with regulatory requirements, ethical guidelines, and scientific validity. Manage the development of clinical evidence for pre-market trials and the entire product lifecycle.
People Leadership:
Lead, mentor, and develop the clinical research team, managing performance assessments, staff goals, and employee training. Provide guidance on site initiation, execution, and closeout activities. Foster a high-performance culture within the team.
Regulatory Strategy:
Collaborate with the regulatory team to develop strategies for timely product approvals, including preparing and revising the Investigational Plan (study protocols, CRFs, etc.), ensuring compliance with global regulatory bodies.
Budget and Cost Management:
Manage study and cost-center budgets, ensuring the clinical research projects are completed on time and within budget.
Cross-Functional Collaboration:
Interface with R&D, manufacturing, sales, marketing, and regulatory affairs to drive clinical-wide and cross-departmental initiatives. Represent the clinical team in internal and external audits.
Clinical Site Coordination:
Collaborate with study sites to ensure activities align with study needs. Maintain strong relationships with external parties, including investigators and CROs.
Post-Clinical Activities:
Assist in post-clinical activities, including product market launches and study result publications for medical literature and scientific meetings.
Must Have (Minimum Requirements):
Nice to Have (Preferred Qualifications):
While performing the duties of this job, employees are regularly required to:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
For more details about Medtronic's benefits and compensation, click here.
We are engineers at heart, tackling the world’s most complex health challenges with a diverse, global team of 90,000+ passionate people. From research and development to manufacturing and marketing, we innovate to create life-changing solutions for people around the world.
Inclusion & Diversity: At Medtronic, we believe that diversity drives innovation. We foster a culture of inclusivity and work together to create meaningful solutions for patients, customers, and business partners.
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