Senior Manager, Clinical Trials

Role: Senior Clinical Project Manager responsible for operational management and execution of global clinical trials for medical devices, including feasibility, pilot, and pivotal studies. Main objectives include ensuring trials are delivered on time, within budget, and compliant with GCP, ISO 14155, and FDA regulations. Responsibilities encompass study planning, site and vendor management, regulatory compliance, documentation, and cross-functional collaboration across Medical Affairs, Regulatory, Data Management, Quality, and external partners. Oversees CRO/vendor performance, monitors trial progress, manages budgets, and supports regulatory submissions. Qualifications: Bachelor's degree in life sciences or nursing, with at least 8 years of clinical research experience in the medical device industry, including leading end-to-end trial execution, vendor oversight, and site management. Preferred: experience in aesthetic energy-based devices, industry certifications (CCRPs, ACRP-CP), and global trial management. High-value: focus on device studies supporting marketing claims/regulatory submissions, GCP/ISO compliance, and cross-functional stakeholder engagement. Work setup involves minimal travel (~25%) to sites and headquarters in the US, with a competitive compensation package.