**Working Location: Nationwide** **Workplace Flexibility: Remote** **_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. ​_** **_​_** ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values empower us to achieve Our Purpose: **Patient Focus, Integrity, Innovation, Impact and Empathy.** Learn more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** This role is responsible for driving and overseeing the operational execution of large-scale, complex clinical trials and/or multiple concurrent strategic studies supporting clinical evidence generation objectives. This role manages study timelines, budgets, vendors, and operational deliverables while coordinating cross-functional study teams in a hub-and-spoke model to ensure efficient study execution. In addition, this role operates in a coach-plus-player model, maintaining direct accountability for assigned studies (as applicable) while providing people leadership, guidance, and development support to Clinical Project Management staff. Operating with a high degree of independence, this role serves as the central point of coordination for the study core team, ensuring alignment across functional partners and maintaining accountability for study progress. This role is responsible for proactively identifying and managing risks, monitoring operational performance, and ensuring studies are delivered on time, within budget, and in compliance with applicable regulations and standards, including GCP, ICH, and FDA requirements. In close collaboration with the Director, Clinical Project Management and Clinical Quality Affairs, develop and maintain Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations. This role could also serve as the primary communicator of study status, providing clear and concise updates to internal stakeholders and leadership through regular reporting and presentations, and ensuring transparency around key milestones, risks, and overall study progress. **Job Duties** + Lead operational execution of complex clinical trials from study start-up through closeout, ensuring delivery against study timelines, budgets, and operational milestones. + Serve as the central hub for the study core team, coordinating activities across Clinical Strategy, Data Management, Biometrics, Monitoring, Site Management, Data Systems, and Clinical Trial Associates. + Ensure cross-functional alignment and accountability for study deliverables, tracking progress across functional areas and escalating risks, delays, or resource constraints to functional leadership when needed. + Oversee end-to-end clinical trial operations, including site start-up, contract and site budget review processes, enrollment progress, monitoring strategy, vendor performance, and study closeout. + Manage study timelines, budgets, and operational metrics, including budget forecasting and tracking of study financial performance. + Coordinate the development of key study documents and operational plans, including protocols, CRFs, informed consent form (ICF), monitoring plan, data management plan, training plan, safety plan, etc. + Coordinate safety oversight activities, supporting collaboration with Safety and Medical teams and operational coordination of DSMB, CEC, and other study governance committees. + Ensure data integrity, regulatory compliance, and inspection readiness, partnering with Data Management, Biometrics, and Clinical Quality Assurance (CQA) to support data review, safety reporting, protocol deviation management, and audit preparedness. + Manage CROs and external vendors, ensuring adherence to study plans, timelines, and performance expectations. + Communicate study status, risks, and key milestones through regular reporting and presentations to internal stakeholders and senior leadership. + Support investigator and site engagement, including investigator meetings, site training coordination, and enrollment oversight. + Provide direct oversight, mentorship, and performance feedback to assigned Clinical Project Management staff while maintaining hands-on responsibility for study execution. + Support onboarding, training, workload balancing, and professional development of CPM team members. + Provide mentorship and operational guidance to clinical project management staff and contribute to improvements in clinical operations processes. **Job Qualifications** **Required:** + Bachelor's degree in health sciences or related field and a minimum of 12 years of clinical trial management experience or an equivalent combination of education and work experience. + Experience managing scope, budget and timel