Senior Clinical Research Specialist.
3 maanden geleden
Careers that Change Lives
Are you ready for this exciting role as a Senior 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. Maastricht with hybrid working possibilities and ability to travel (10-20%).
Peripheral Vascular Health Operating Unit
Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
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 clinical study documents i.e 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.
Must Haves
• Bachelor’s degree required in engineering, life sciences, or related medical/scientific field
• At least a minimum of 4 years of clinical research experience (i.e., in the development and execution of clinical studies) or Master degree/Phd with a minimum of 2 years of clinical research experience.
• Experience managing multiple clinical research sites with proven results in study execution
• Experience developing clinical strategies and study design
Nice to Haves
• Clinical Research/clinical trial experience at Medtronic or within a medical device industry
• PMP certification; Project Management Certification and/or Green Belt Certification
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
• Experience developing clinical strategies and study design
• Experience in Peripheral Vascular therapies/product
We Offer
We offer a competitive salary and benefits package to all our employees:
• Flexible working environment
• Annual Incentive Plan % depending on company results
• Pension scheme and group discount on healthcare insurance
• Training possibilities via Cornerstone/Skills Lab
• Employee Assistance Program and Recognize (our global recognition program)
Our Commitment
Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.
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