Clinical Trials Manager - Center for Interventional Cardiovascular Research & Clinical Trials

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.

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.

• Bachelor's degree in nursing, Biology, and Public Health or related scientific/health field (life sciences, health administration, etc) required. Master's degree or equivalent advanced training in clinical research or project management preferred.
• 6+ years of experience managing clinic