Sr Prin Field Clinical Research Specialist

MiniMed•Virtual, PA

3d•Remote

About The Position

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. We’re looking for a seasoned clinical research professional with strong leadership, communication, and problem-solving skills. A key member of the team to lead the technical aspects of New Venture programs. In this exciting role as a Field Clinical Research Specialist, you will have responsibility for providing technical diabetes leadership to the Centers of Excellence and cross-functional New Venture programs. DIABETES Transforming diabetes care together, for greater freedom and better health. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Visit https://www.minimed.com/ to see an overview of the product portfolio. NEW VENTURES New Ventures is focused on developing new diabetes systems, products and solutions in an inorganic, accelerator environment. Our team is unique in that we can adapt to a variety of business, patient and marketplace needs that span the entire spectrum of our product portfolio today and in the future. Our mission drives the need to be a highly skilled, flexible, extremely efficient, versatile and agile in medical device product development for the benefit of our patients with Type 1 and Type 2 diabetes in need of intensive insulin therapy. FIELD CLINICAL RESEARCH SPECIALIST In this exciting role as a Field Clinical Research Specialist, 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. The Clinical Specialist will support research and development in evaluating concepts for new therapy and product development and the modification of existing devices; serving as a clinical resource between engineering, leadership, clinical research, and the medical community. Among these responsibilities, the highest priority is given to the support of patients. We will strive to empower people with diabetes to live life on their terms by delivering a pump that truly matters and providing support in ways that is needed. We are committed to meeting people with diabetes in their journey, always with an aim to make their life easier. Our focus is to provide a better life, better health, greater freedom and extend their lives of people living with diabetes.

Requirements

Bachelor’s degree required and minimum of 7 years of clinical research experience, or advanced degree with a minimum of 5years clinical research experience
Proficient knowledge of medical terminology.
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
Excellent project management and organization skills.

Nice To Haves

Degree in engineering, life sciences, or related medical/scientific field.
Clinical Research (Lead) experience at Medtronic or within a medical device industry.
Experience working on a Global study team
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
Experience in managing multiple clinical research sites with proven results in study execution
Experience in managing clinical trial data review.
Ability to incorporate and adhere to good clinical practices and regulatory standards.
Ability to identify and implement solutions in addressing study issues.
Basic understanding of biostatistics and trial design.

Responsibilities

Technically lead field activities such as selecting sites, performing activation duties such as certification of clinical centers both nationally and internationally, providing training, helping to enroll participants, providing technical support and ensuring quality data acquisition.
Identify and support new clinics that may want to establish capability based on existing clinical models
Identify and educate new patients, 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 by providing feedback on patient voice for current and next generation product.
Train and mentor clinical staff and product development team
Oversees 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 and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
Support clinical logistics with key centers, HCPs and patients for clinical research activities on a national and international level
Support IRB submissions for next generation product
Support the geographical expansion of centers