Manager, Clinical Operations

Manage a high performing clinical operations team by providing direction, subject matter expertise, training and mentorship. Responsible for managing the design, development, modification, and evaluation of clinical execution plans (e.g., protocol, case report forms, consent forms, source document worksheets, budget, timelines, gap analysis, etc.) Accountable for the comprehensive clinical trial activities including but not limited to study start-up, site activation, site management, vendor oversight, study reports, site and study close-out. Provide technical direction to clinical research organizations (CROs) and oversee vendor selection/management as needed to execute clinical studies. Work closely with hospitals and investigators participating in clinical studies and maintain close working relationships with KOLs, other investigating physicians and site coordinators. Provide input and support for post-clinical activities and market launch of products. Establish / support cross-functional teams to ensure optimal alignment of Clinical, Regulatory, commercial goals, site operations, data monitoring and review, and safety surveillance and reporting expectations. Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulations. Requirements Bachelor’s degree in a scientific field Minimum 8+ years of relevant clinical research experience in the medical device field, or an advanced degree with a minimum of 5 years of relevant experience in the medical device field At least 2 years monitoring experience Experience with Class III medical device clinical studies Proven success building and managing clinical operations teams Comprehensive knowledge of clinical operations including Good Clinical Practices and all applicable US regulations Experience with global clinical studies (e.g., EU or APAC regions) Effective verbal and written communication skills Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail Must be a strong team player and effectively interface with other departments including translational medicine, regulatory, quality, product development. Core Competencies Demonstrates extensive experience in managing clinical operations teams and executing clinical studies in compliance with Good Clinical Practices and applicable regulations. Proven ability to oversee clinical trial activities, vendor management, and cross-functional collaboration to achieve clinical and commercial goals. Highest-signal resume keywords Clinical Operations Management Clinical Trial Activities Good Clinical Practice (GCP) Medical Device Clinical Studies Team Leadership ATS Optimization Keywords Hard Skills Clinical Research Clinical Execution Plans Site Management Vendor Oversight Budget Management Gap Analysis Study Reports Regulatory Compliance Data Monitoring Clinical Protocol Development Soft Skills Effective Communication Organizational Skills Self-Motivation Attention to Detail Team Collaboration Industry Keywords Clinical Research Organizations (CROs) Class III Medical Devices Global Clinical Studies US Regulations KOL Relationships #J-18808-Ljbffr