Senior Manager, Clinical Operations

About the role

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.

Responsibilities

• 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.
• Absess 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.
• Set a professional example in alignment with ZOLL’s Leadership Qualities.
• Execute company strategic business plans and long and short-term objectives.

Requirements

• 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.

Preferred Experience

• Knowledge of Good Clinical Practice (GCP) and applicable global regulations and standards, including ISO, Code of Federal Regulations (CFR), and European Medical Device Regulation (MDR).
• Strong clinical background with a comprehensive knowledge and application of business concepts, procedures and practices.
• Strong project management skills with the ability to manage multiple priorities and meet deadlines.
• Advanced analytical and problem-solving skills, including the ability to assess complex situations and evaluate multiple technical and strategic options.
• Proven 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.
• Ability to perform work with general direction, exercising sound judgement and initiative in managing projects and assignments.
• 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.