Principal Clinical Research Specialist - Neurovascular

Careers That Change Lives

In this exciting role as a Principal Clinical Research Specialist (CRS) you will have primary responsibility in the development and execution of clinical studies and for developing and overseeing clinical strategies for effectively assessing performance related to the ongoing evaluation of product safety and effectiveness following market release. You will lead study management duties and drive processes to meet the milestones of complex clinical studies/projects for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Assumes project management responsibilities for selected studies and site management activities as needed.

This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and may be global in nature. This role works independently and under only general direction. The position provides work direction and strategic oversight of personnel supporting their trial.

Neurovascular Operating Unit

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.

The Neurovascular Team develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

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 open the lhe following link:

https://www.medtronic.com/us-en/about/careers/inclusion-diversity.html

Location: Office-based in Maastricht or Remote within Europe

Ability to travel up to 25%.

A Day in the Life

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

• Oversees, designs, plans, and develops clinical evaluation research studies for products that are under Clinical Investigation
• Prepares and authors protocols and patient record forms
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential
• Oversees and interpret results of clinical investigations in preparation for new device or consumer application
• Oversees and manages operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets
• Serves as liaison between program management and planning, study team, and leadership
• Provides work direction to a cross-functional team which includes site managers, monitoring, safety, stats, and others
• Reviews status of projects and budgets; manages schedules and prepares status reports
• May be responsible for clinical supply operations, site and vendor selection
• 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 optimal relationships and effective collaborations with various internal and external parties
• Drives local evidence dissemination & awareness

Other Responsibilities:

• Collaborates closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives
• Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation