Jobs · Analyst · New Jersey

Clinical Trial Manager

Health Here · Princeton, NJ · 1 wk ago
On-siteAnalystFull-time
Role Overview: The Senior Clinical Trial Manager (CTM) is responsible for leading the operational aspects of global clinical trials to ensure timely, compliant, and high-quality execution. This role involves strategic planning, setup, and oversight of trial activities, managing documentation, and ensuring inspection readiness. Key Responsibilities Lead trial planning, setup, and execution, ensuring adherence to regulatory and quality standards.Manage trial documentation, systems, and data quality, driving continuous inspection readiness.Coordinate site feasibility, selection, and activation with CROs and internal teams.Oversee CROs and service providers, ensuring deliverables meet timelines and quality expectations.Identify and mitigate operational risks through risk-based quality management.Address protocol deviations, issue escalation, and resolve trial challenges effectively.Monitor trial performance metrics, utilizing data to inform decisions and improvements.Foster cross-functional collaboration among internal teams, vendors, and investigators. Qualifications & Skills Bachelor’s degree in life sciences or related field; Master’s preferred.8+ years of clinical trial management experience, with a focus on global, multi-center trials.Deep understanding of ICH/GCP regulations and drug development processes.Strong project management, vendor oversight, and communication skills.Experience in oncology or relevant therapeutic areas is highly desirable.Ability to lead autonomously and mentor cross-functional teams.

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