Careers That Change Lives

In this exciting role as a Senior Clinical Research Specialist (CRS), you will have primary focus responsibility leading study management projects for assigned clinical programs to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. You will oversee, design, plan and develop clinical projects for assigned clinical programs and w ork with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Under direct supervision, assumes project management responsibilities for selected studies and site management activities as needed.

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

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.

Location: Remote within the United States. Strong preference for local candidates in the L.A./Northridge, CA area.

Travel up to 10-15%.

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.
• 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 resolves 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.
• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Responsible for overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
• Participates in overall clinical management plan, protocol and case report form development.
• Responsible for site initiation activities, resolution and follow-up of site issues, and study closure activities. May be responsible for clinical supply operations, site and vendor selection.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance. Assists in preparation of study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files.
• Performs data review, reviews data discrepancies, generates reports. May assist with publication of study data in medical literature and/or presentation at scientific meetings
• May interface with representatives from key functional groups including Product Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs.
• Assists clinical management with other duties as requested.
• May be responsible for clinical supply operations, site and vendor selection.