Clinical Operations Senior Manager

Role: Senior Clinical Project Manager overseeing global Phase I–III cardiovascular clinical trials, ensuring timely initiation, execution, and reporting in compliance with GCP/ICH standards. Responsibilities: independently managing trial operations from start-up to database lock; leading cross-functional teams and CRO collaborations; participating in protocol design, site and vendor selection, and regulatory submissions; overseeing site monitoring, data quality, and safety reporting; managing budgets, site payments, and supply logistics; ensuring audit readiness and regulatory compliance. Requirements: Bachelor’s in health or biological sciences; 7+ years in clinical operations, including 3+ years as a clinical study lead; extensive experience managing domestic and international early and late-phase trials, particularly in cardiovascular or rare diseases; strong vendor/partner management, risk mitigation, and project management skills; deep knowledge of GCP, FDA regulations, and clinical data standards; proficiency with eClinical systems and Microsoft Office. Preferred: Master’s degree; experience with regulatory submissions (INDs, CTAs, BLAs, NDAs); site monitoring and clinical quality compliance expertise; global trial experience. High-Value: cardiovascular indications, Phase I–III trials, clinical operations leadership, regulatory documentation, vendor oversight, trial start-up, and audit preparedness. Location: onsite Lexington, MA; travel not specified.