• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversees site interactions post activation through site closeout • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. • Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. • Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. • Document requested revisions and approvals in CTMS. • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. • Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. • Supports Inspection Readiness for clinical trial management scope. • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. • May develop and support execution of corrective action plans at site and study level. • Supports and completes activities to achieve data cut and lock deadlines. • Provides feedback to line managers on staff performance including strengths as well as areas for development. • May be assigned to larger,more complex trials.

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout, which may include patient recruitment, investigator payments or other related activities. • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables and escalates any risks to the project manager. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones.

Title: Senior Manager, Clinical Operations Location: Minnetonka United States Job Description: Respicardia At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life. We develop breakthrough therapies for an impactful disease that is severely underdiagnosed and often untreated. As we continue to grow, those who join our team will work alongside motivated people who care about others, put patients first and are dedicated to high-quality and innovative solutions. Job Type / Location Hybrid - Minnetonka, MN This role offers a hybrid schedule, with an expectation of spending 3 to 4 days per week in our Minnetonka office. Being in the office regularly helps with team connection, collaboration, and staying plugged into the day-to-day, while still offering flexibility to work remotely. You'll partner with your team both in person and virtually to build relationships, support their work, and contribute to a strong, high-performing environment. Job Salary Annual Base Salary: $150,000-$175,000 This position is bonus eligible. Job Summary This position is responsible for leading a growing team to ensure excellence in the design, development, and execution of clinical trials in collaboration with Clinical Operations and cross-functional partners. It provides strategic and operational leadership to ensure that team activities are consistent with legal and regulatory standards and company policies. This role combines people management with hands-on contribution, overseeing key Clinical Affairs functions and supporting clinical strategy and execution. Essential Functions - Lead and manage clinical trial operational execution, including site and principal investigator identification, subject recruitment, investigator meetings, monitoring, trial master files maintenance and resolution of site performance issues. - Develop clinical study protocols, procedures and supporting documentation to support new clinical projects at all phases of development. - Manage internal teams, Contract Research Organizations (CROs), vendors, and consultants supporting site management and trial operations. - Ensure appropriate resource allocation and prioritization across assigned clinical programs. - Develop and manage study budgets and timelines. - Implement and manage remote and risk-based monitoring strategies. - Lead cross-functional team meetings and provide regular updates to senior leadership. - Manage clinical activities, including study initiation for clinical sites, site recruitment and preparation, facilitation of Institutional Review Board (IRB) approvals process and readiness for enrollments. - Participate in initial and transitional education for clinical site personnel and field team representatives (e.g., Territory Managers, Clinical Specialists) on protocols, processes, and products. - Ensure compliance with appropriate regulatory requirements (e.g., International Council for Harmonization Good Clinical Practice (ICH-GCP), Competent Authorities (CA), Ethics Committees (EC)) and internal Standard Operating Procedures (SOPs), Work Instructions (WI), policies, and procedures. - Support audit readiness and provide management level representation during audits. - Maintain and update internal documentation as needed. - Provide meaningful, timely, and accurate updates to executive level leadership as needed. - Maintain and monitor team workload, performance, and quality. - Assess and manage direct reports' learning and development opportunities. - Conduct annual and ongoing performance reviews with recommendations for compensation changes, promotions, and disciplinary action as appropriate. - Participate in the interviewing, hiring, and retention of highly engaged and diverse employees. - Set a professional example in alignment with ZOLL's Leadership Qualities. - Execute company strategic business plans and long and short-term objectives. Required/Preferred Education and Experience - Bachelor's Degree in a scientific field required with demonstrated clinical research experience; advanced degree preferred - 5+ years of leadership experience in clinical or scientific research within the medical device industry; experience in the fields of cardiology or sleep medicine preferred - Minimum of 3-4+ years of direct people management experience, including leading and developing teams - Experience with Premarket Approval (PMA) device preferred - Demonstrated people management experience, including performance evaluations and development of employee goals and objectives - Experience working with clinical research centers across all phases of clinical trials, including site activation, enrollment and closeout - Proficiency with clinical trial management systems, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and electronic Trial Master Files (eTMF) - Experience applying and implementing risk-based quality management and risk-based monitoring approaches - Proven ability to collaborate with stakeholders within multiple organizational levels on significant matters, often requiring coordination across functions Knowledge, Skills and Abilities - Strong clinical background with a comprehensive knowledge and application of business concepts, procedures and practices - Proficiency in Good Clinical Practice (GCP) and applicable global regulations and standards, including ISO, Code of Federal Regulations (CFR), and European Medical Device Regulation (MDR) - Excellent verbal and written communication skills, with the ability to effectively engage clinicians, key opinion leaders, and senior leadership - Strong project management skills with the ability to manage multiple priorities and meet deadlines - Ability to develop and execute clinical trial strategies aligned with organizational objectives - Advanced analytical and problem-solving skills, including the ability to assess complex situations and evaluate multiple technical and strategic options - Demonstrated ability to work effectively in a cross-functional, team-oriented environment and manage competing priorities - Strong business acumen with the ability to link internal and external activities with market trends in the clinical trial space to drive operational efficiencies - Able to perform work with general direction, exercising sound judgement and initiative in managing projects and assignments - Ability to interpret, communicate, and present clinical data clearly to diverse audiences - Proven interpersonal and leadership skills, with the ability to influence and build relationships with physicians, customers, and stakeholders - Effective team leadership skills, with the ability to perform in a fast-paced, high-visibility environment Travel Requirements - Ability to travel (including overnight stays) 25% Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. - Standing - Occasionally - Walking - Occasionally - Sitting - Constantly - Talking - Occasionally - Hearing - Occasionally - Repetitive Motions - Frequently ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. The annual salary for this position is: $150,000.00 to $175,000.00 This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com. Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

• Serve as primary point-of-contact and primary escalation point to the client • Coordinate and oversee all functional services including external vendors to the established timeline and budget • Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled appropriately. • Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly. • Manage the financial health of assigned studies, including oversight of project profitability, billable project hours, and compliance with on-time, accurate billing and forecasting to support business objectives. • Develop robust and comprehensive project plans, including timelines and proactive risk management to guide all parameters of trial execution with consistency and quality • Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and/or corrective and preventative action plans to address any quality findings. • Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation • Establish tracking metrics to monitor trial and team progress towards project goals • Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise • Lead both internal and client meetings and set expectations for the project team • Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues • Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project • Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required • Perform other duties as assigned by management • Remain compliant with organizational training, time-reporting and any other administrative duties as required • Provide ongoing feedback for functional team members including annual performance reviews • Ability to travel domestically and internationally including overnight stays