Senior Manager, Clinical Trials

Role: Senior Clinical Project Manager overseeing global clinical trials for medical device products, ensuring timely, compliant execution from feasibility to close-out. Responsibilities include managing trial operations, site relationships, vendors, regulatory adherence, and clinical documentation, with a focus on device studies for marketing and regulatory submissions. Coordinates cross-functionally with Clinical, Regulatory, Data Management, and Medical Affairs teams; manages vendor performance and oversees quality assurance activities aligned with GxP standards. Qualifications: Bachelor's in life sciences or nursing; 8+ years in clinical research within the medical device sector; proven leadership in trial execution, vendor oversight, and site management; knowledge of GCP, ISO 14155, and regulatory reporting. Preferred: experience in aesthetic energy-based devices, industry certifications (e.g., CCRP), and global trial management. High-value: medical device development, aesthetic indications, GCP/ISO 14155 compliance, cross-functional stakeholder collaboration, and international regulatory standards. Work setup: locations in Irvine, San Francisco, Boston, and Bothell; approximately 25% travel. The role requires excellent organizational, communication, and risk management skills, with proficiency in MS Office, EDC, and CTMS systems.