Senior Manager, Clinical Operations

ZOLL Medical•Minnetonka, MN

8d•Hybrid

About The Position

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.

Requirements

Bachelor's Degree in a scientific field required with demonstrated clinical research experience
5+ years of leadership experience in clinical or scientific research within the medical device industry
Minimum of 3–4+ years of direct people management experience, including leading and developing teams
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
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

Nice To Haves

advanced degree preferred
experience in the fields of cardiology or sleep medicine preferred
Experience with Premarket Approval (PMA) device preferred

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.
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.