In this exciting role as a Clinical Research Manager (CRM), you will have primary focus responsibility to oversee all clinical activities related to one or more clinical studies and performing/directing/managing the daily in-house activities associated with the studies. This is a people leadership role. The CRM will report to the US Sr. Clinical Research Director and independently handle various clinical study assignments, have management responsibility, and oversees and directs the work of a team of Clinical Research Specialists at all levels, from entry level to tenured. Responsibilities include providing leadership for the conduct of clinical studies and regulatory affairs related to product approval, ensuring studies are scientifically valid and meet regulatory and ethical guidelines, developing and implementing regulatory strategies for product approvals worldwide, representing Medtronic in clinical research within the country/region, building strong networks with internal and external parties, managing clinical research projects across multiple therapies, preparing and revising clinical study documents, supervising training and site initiation activities, managing budgets, overseeing clinical research staff, interfacing with regulatory agencies and key functional groups, overseeing activities performed by Contract Research Organizations, supporting post-clinical activities and market launch, and co-authoring study results. Minimum requirements include a Bachelor's degree and at least 5 years of clinical research experience or an advanced degree with 3 years of experience. Preferred qualifications include advanced degrees, leadership skills, global teamwork experience, medical device clinical trial experience, cost-center management, expertise in Good Clinical Practice, clinical trial design and execution, and product development experience. The role involves up to 25% travel (domestic and possibly international).
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