Clinical Operations Manager

Respicardia Job OpportunityAt 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.Job Type / Location: Hybrid - Minnetonka, MNThis 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.Annual Base Salary: $150,000-$175,000This 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 preferred5+ years of leadership experience in clinical or scientific research within the medical device industry; experience in the fields of cardiology or sleep medicine preferredMinimum of 3–4+ years of direct people management experience, including leading and developing teamsExperience with Premarket Approval (PMA) device preferredDemonstrated people management experience, including performance evaluations and development of employee goals and objectivesExperience working with clinical research centers across all phases of clinical trials, including site activation, enrollment and closeoutProficiency 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 approachesProven ability to collaborate with stakeholders within multiple organizational levels on significant matters, often requiring coordination across functionsKnowledge, Skills and Abilities:Strong clinical background with a comprehensive knowledge and application of business concepts, procedures and practicesProficiency 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 leadershipStrong project management skills with the ability to manage multiple priorities and meet deadlinesAbility to develop and execute clinical trial strategies aligned with organizational objectivesAdvanced analytical and problem-solving skills, including the ability to assess complex situations and evaluate multiple technical and strategic optionsDemonstrated ability to work effectively in a cross-functional, team-oriented environment and manage competing prioritiesStrong business acumen with the ability to link internal and external activities with market trends in the clinical trial space to drive operational efficienciesAble to perform work with general direction, exercising sound judgement and initiative in managing projects and assignmentsAbility to interpret, communicate, and present clinical data clearly to diverse audiencesProven interpersonal and leadership skills, with the ability to influence and build relationships with physicians, customers, and stakeholdersEffective team leadership skills, with the ability to perform in a fast-paced, high-visibility environmentTravel 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 - OccasionallyWalking - OccasionallySitting - ConstantlyTalking - OccasionallyHearing - OccasionallyRepetitive Motions - FrequentlyZOLL 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.