[Hiring] Senior Principal Field Clinical Research Specialist @MiniMed

Role Description

MiniMed is seeking an experienced Sr. Principal Field Clinical Research Specialist to support and lead clinical research initiatives, ensuring high-quality clinical data and compliance with applicable regulatory requirements. This role will collaborate cross-functionally with clinical, medical, and research teams to support study execution, site management, and overall clinical trial success. The position is fully remote and open to candidates anywhere in the United States, with travel required as needed to support clinical study activities.

• Lead the technical aspects of New Venture programs.
• Provide technical diabetes leadership to the Centers of Excellence and cross-functional New Venture programs.

In this exciting role, you will be responsible for overseeing and executing clinical programs for a powerful, developing therapy to treat a small but critical cohort of patients on a humanitarian basis. Leveraging a broad and diverse clinical experience and skillset, you will provide clinical and technical leadership to key centers, HCPs, and patients on a national and international level.

• Support research and development in evaluating concepts for new therapy and product development.
• Serve as a clinical resource between engineering, leadership, clinical research, and the medical community.
• Empower people with diabetes to live life on their terms by delivering a pump that truly matters.
• Focus on providing a better life, better health, greater freedom, and extending the lives of people living with diabetes.

A Day in the Life

• Technically lead field activities such as selecting sites and performing activation duties.
• Identify and support new clinics that may want to establish capability based on existing clinical models.
• Identify and educate new patients and physicians on new therapy development.
• Troubleshoot clinical and technical issues related to therapy and product.
• Provide clinical input for user needs, product development, and user validation.
• Train and mentor clinical staff and product development team.
• Oversee and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Build and maintain optimal relationships and effective collaborations with various internal and external parties.
• Oversee and resolve operational aspects of clinical trials in conjunction with project teams.
• Support clinical logistics with key centers, HCPs, and patients for clinical research activities.
• Support IRB submissions for next generation product.
• Support the geographical expansion of centers.

Qualifications

• Bachelor’s degree required and minimum of 7 years of clinical research experience, or advanced degree with a minimum of 5 years clinical research experience.
• Degree in engineering, life sciences, or related medical/scientific field (desired).
• Clinical Research (Lead) experience at Medtronic or within a medical device industry (desired).
• Experience working on a Global study team (desired).
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials (desired).
• Experience in managing multiple clinical research sites with proven results in study execution (desired).
• Experience in managing clinical trial data review (desired).
• Basic understanding of biostatistics and trial design (desired).
• Proficient knowledge of medical terminology (desired).
• Proficiency in MS Office applications: Excel, PowerPoint, Word, Project (or similar scheduling software) (desired).
• Excellent project management and organization skills (desired).

Benefits

• Competitive salary and flexible benefits package.
• Health, dental, and vision insurance.
• Access to a Health Savings Account and Healthcare Flexible Spending Account.
• Life insurance and long-term disability leave.
• Dependent daycare spending account.
• Incentive plans and a 401(k) plan with company match.
• Paid time off and holidays.
• Participation in Employee Stock Purchase Plan.
• Access to Employee Assistance Program.
• Non-qualified Retirement Plan Supplement and Capital Accumulation Plan (subject to IRS minimum earnings requirements).