Sr. Manager, Clinical Operations

Senior Manager, Clinical OperationsWork Location: Middlesex County, MassachusettsSummary:The Senior Manager, Clinical Operations is responsible for overseeing daily clinical site operations, leading study teams, ensuring regulatory compliance, and driving high-quality execution of clinical trials. This role involves staff management, operational oversight, and collaboration with cross-functional teams to meet study and business objectives.Responsibilities:Direct daily site operations, monitor study activities, enrollment, and performance metrics for both inpatient and outpatient clinical trials.Oversee subject recruitment, eligibility assessments, randomization, and ensure accurate documentation and safety event reporting.Identify and mitigate operational, regulatory, or safety risks, escalating critical issues as needed.Lead, train, and develop clinical research staff, assign responsibilities, and track involvement across studies.Manage recruitment, hiring, and onboarding of site personnel, and conduct regular team meetings to review progress.Oversee facility maintenance, equipment calibration, and manage vendor contracts for study-related services.Ensure protocol and regulatory compliance, support quality assurance checks, and assist with audit preparation.Facilitate communication between site teams, sponsors, and external stakeholders, and generate site performance reports.Qualifications:Bachelor’s degree required.Minimum 2 years of people management experience in clinical research.5+ years of clinical research experience preferred; hands-on experience as a Clinical Research Coordinator is a plus.Prior research site management experience is a plus.Knowledge of GCP, FDA regulations, and clinical trial protocols.Excellent communication, collaboration, and organizational skills.Strong decision-making and problem-solving abilities.Ability to prioritize competing responsibilities in a fast-paced environment.