Bachelor's Degree in Biology, Public Health, or related field; Master's preferred
4-5 years of research experience with clinical trials exposure
1 year in a management or leadership role
Experience in cardiovascular research or interventional clinical trials strongly preferred
Strong understanding of FDA, ICH/GCP regulations
Responsibilities
Supervise Clinical Trial Management and Research Coordination teams
Oversee hiring, onboarding, and performance management
Serve as the operational point of escalation for complex study issues
Manage daily operations of assigned clinical trials
Develop and maintain study timelines and risk mitigation frameworks
Ensure compliance with regulatory standards for all study activities
Support protocol development and contribute to study-specific documentation
Benefits
Professional development opportunities
Collaborative work environment
Mentorship and structured training programs
Exposure to cutting-edge cardiovascular research
Engagement with cross-functional teams and external partners
Full Job Description
Job Description
The Clinical Trial Manager provides leadership and oversight for the planning, conduct, and management of clinical trials within the Center for Interventional Cardiovascular Research & Clinical Trials. This role ensures high-quality, efficient study execution consistent with institutional, FDA, and ICH/GCP standards. The Manager leads cross-functional study teams, supports the Principal Investigators and Center leadership in strategic research goals, and implements best practices in clinical trial management, monitoring, vendor oversight, data quality, and regulatory compliance across multiple studies.
Responsibilities
Leadership & Supervision
Supervise the Clinical Trial Management and Research Coordination teams.
Oversee hiring, onboarding, and performance management, promoting collaboration and professional development.
Serve as the operational point of escalation for complex study issues requiring strategic resolution.
Provide mentorship and structured training to staff on best practices in trial conduct and monitoring.
Operational Oversight
Manage daily operations of assigned clinical trials to ensure protocol adherence, regulatory compliance, and timely execution.
Develop and maintain study timelines, enrollment targets, site performance plans, and risk mitigation frameworks.
Coordinate communication among investigators, sponsors, and institutional departments to ensure cohesive study conduct.
Oversee site qualification, selection, activation, ongoing management, and remediation where needed to support enrollment and data quality goals.
Regulatory & Quality Management
Ensure compliance with FDA, ICH/GCP, IRB, and institutional standards for all study-related activities.
Oversee regulatory submissions, continuing reviews, reportable event documentation, safety reporting, and correspondence with IRBs and sponsors.
Maintain the Trial Master File (TMF) and site investigator files in inspection-ready status.
Monitor study enrollment, safety reporting, and data accuracy to ensure high-quality deliverables.
Lead internal and external audit readiness and serve as primary operational contact during sponsor, institutional, or regulatory audits.
Support development and implementation of centralized and risk-based monitoring strategies.
Study Design, Start-Up & Conduct
Support protocol development and review; contribute to drafting informed consent forms (ICFs), operational workflows, and study-specific procedure manuals.
Lead development and revision of study monitoring plans, data management plans, MOPs/SOPs, core lab manuals, and training materials.
Oversee EDC and CRF development, validation testing, and user feedback cycles in collaboration with data management and biostatistics.
Conduct or oversee site qualification, initiation, routine monitoring, and closeout visits.
Lead Investigator Meetings, Site PI meetings, vendor kickoff sessions, and study milestone reviews.
Budget & Resource Management
Contribute to development and negotiation of study budgets, vendor agreements, subcontracts, and change orders.
Forecast personnel effort, study expenditures, vendor invoices, and milestone payment schedules.
Monitor budget adherence, reconcile financial variances, and recommend resource adjustments to ensure operational efficiency.
Vendor & Stakeholder Oversight
Oversee performance of vendors including imaging core labs, EDC/CTMS providers, CROs, and specialty service partners.
Ensure vendor deliverables, timelines, reporting, and quality expectations are met.
Coordinate with external academic, industry, and consortium partners to ensure aligned study execution.
Data & Reporting
Collaborate with biostatistics and data management teams to ensure data accuracy, timely query resolution, and database lock.
Support interim and final data analyses, clinical study reports (CSRs), abstract submissions, conference presentations, and manuscript development.
Track and report key trial performance metrics to leadership and sponsors on an ongoing basis.
Performs other related duties.
Qualifications
Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred
4-5 years of research experience with exposure to clinical trials and 1 year in a management/leadership role
Experience in cardiovascular research or interventional clinical trials strongly preferred
About Mount Sinai Hospital
Mount Sinai Hospital is a hospital network based in New York City. It was founded in 1852 and is one of the oldest and largest teaching hospitals in the United States. The hospital has been ranked among the top hospitals in the country by U.S. News & World Report and is known for its excellence in patient care, research, and education. Mount Sinai Hospital is affiliated with the Icahn School of Medicine at Mount Sinai and has a staff of over 7,000 physicians, nurses, and other healthcare professionals.
