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

The Principal Clinical Research Specialist is responsible for developing strategies and driving processes to meet the milestones of complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. 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 global nature. This role works independently and under only general direction. Major deliverables are reviewed to ensure clinical and business requirements are met. The position provides work direction and strategic oversight of personnel supporting their trial and partners closely with other leaders on the program to ensure program success.

Careers That Change Lives 

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people.

We are currently looking for a highly motivated Principal Clinical Research Specialist to join our Neurovascular Clinical Research and Medical Science organization. Bring your extensive experience with Clinical evidence generation strategy and high-quality execution of clinical studies, to develop and execute strategies for clinical studies to help regulatory approvals and key strategic evidence initiatives.

As a member of the Clinical Research team, you will work with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision. During trial execution, you will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. You will clearly provide guidance to the monitors about monitoring needs and oversee compliance work on the study. You will work closely with site managers, monitors, data management, safety, Clinical scientists and other clinical research members for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or support the development of clinical publications. You will also work with cross-functional stakeholders including medical education, regulatory, R&D, Quality etc., and take a leadership role in external communication with investigators, clinical study sites and study teams. The ideal candidate will have experience previously managing premarket studies in the United States.

 
This position can be remote within the United States, but preference will be given to applicants who can be based in Irvine, California or Fridley, Minnesota.  

Responsibilities may include but are not limited to:

• Accountable for leading assigned clinical research activities
• Accountable for the planning and execution of the clinical studies including site selection, review of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-thorough to ensure successful progress
• Accountable for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliance
• Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
• Perform on-site and remote site qualification visits & site initiation visits.
• Conduct study activities to ensure regulatory and protocol compliance as well as overall data accuracy
• Liaise with sites and help in internal audit/inspection and ensure sponsor audit readiness
• Provide oversight of external vendors
• Track study progress and provide regular status reports
• Work closely with Biostatisticians and clinical scientists on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or help development of scientific publications
• Help prepare study budgets and study financial accruals and forecasts, and oversee site payments 
• Organize and drive study meetings and other study activities as assigned
• Mentor junior clinical study team members 
• Follow SOPs and regulatory requirements and guidelines and proactively manage studies, following such guidelines and requirements
• Help regulatory submission and approval of pre-market clinical