Senior Manager, Clinical Trials

Role: Senior Clinical Project Manager overseeing global clinical trials for medical devices, including feasibility, pilot, and pivotal studies to support marketing claims and regulatory submissions. Responsibilities: manage end-to-end study operations, site relationships, vendor oversight, regulatory compliance, document development, and budget tracking; lead cross-functional collaboration with Medical Affairs, Regulatory, Data Management, and Quality teams; ensure GCP and ISO 14155 compliance, audit readiness, and timely trial delivery. Requirements: bachelor's degree in life sciences or nursing; 8+ years in medical device clinical research; experience managing CROs, vendors, and clinical sites; strong project management, risk mitigation, and communication skills; proficiency with EDC and CTMS; minimal travel (~25%). Preferred: experience in aesthetic energy-based devices, industry certifications (CCRP, ACRP-CP), global trial management, and knowledge of GCP/medical device regulations. High-value: medical device (energy-based devices), clinical development, global trial oversight, regulatory compliance, vendor management, and cross-functional stakeholder engagement.