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Manager, Clinical Operations Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America * Minnetonka, 130 Cheshire Lane, Minnetonka, Minnesota, United States of America Req #2315 Friday, January 3, 2025 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: The Manager, Clinical Operations serves as subject matter expert and advisor to Clinical Operations and Programs teams on Site Management and Trial Operations related matters. This position oversees performance and trends related to site lifecycle management including initiation, execution and closure, monitoring and trial operations services, ensures applicable regulations and standards for medical devices are applied, and clinical program and department commitments are achieved. This position heavily interfaces and collaborates with other functions and departments within the clinical organization, vendors, and contributes to process improvement activities. The Manager, Clinical Operations will establish and ensure compliance with standard processes and best practices, in addition to maximizing metrics and reporting on clinical activities. ESSENTIAL FUNCTIONS OF THE POSITION: Acts as a Subject Matter Expert to the Clinical Programs and Operations team in the development and implementation of key study functions, including but not limited to device supply logistics, financial processes (invoices and payments), essential document and trial master file (TMF) management, audit preparedness, credentialing and select monitoring activities throughout the lifecycle of a trial. Provides work direction, guidance, mentoring and support to Clinical Study Associates (CSAs), Clinical Operations Associates (COAs) and/or Clinical Research Associates (CRAs), on clinical trial operations practices with continuous improvement objectives of efficiency and quality. Participates in the interview and selection of hiring new employees including training and onboarding as applicable Provides oversight and direction in the development and management of clinical trial materials (may include ordering, copying, creating tabs, building binders, review binder content, shipping, and tracking of documents associated with department or study supplies and study devices) Provides oversight and direction in the development of device processes, and logistics from demand planning, device setup in the clinical database, ordering, re-supply and tracking for clinical sites including quality control and filing of documents, and overall device accountability for assigned trials Responsible for tracking trial activity in collaboration with the clinical team, by ensuring receipt of essential documents, including quality c