Clinical Trials Manager - Center for Interventional Cardiovascular Research & Clinical Trials
About The Position
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. The role supports high-quality, efficient study execution in accordance with institutional, FDA, and ICH/GCP standards. The Manager leads cross-functional study teams, supports Principal Investigators and Center leadership in achieving strategic research goals, and implements best practices in trial management, monitoring, vendor oversight, data quality, and regulatory compliance across multiple studies. The position supervises clinical trial management and research coordination teams, oversees study operations and regulatory quality, and leads study start-up, conduct, monitoring, and closeout. It also contributes to study budgets and resource planning, oversees vendors and external partners, and works with data management and biostatistics teams to support accurate data, reporting, analyses, and study deliverables.
Requirements
- Bachelor's degree in Biology, Public Health, or a related scientific or health field.
- Four to five years of research experience with exposure to clinical trials.
- One year in a management or leadership role.
Nice To Haves
- Master's degree.
- Experience in cardiovascular research or interventional clinical trials.
Responsibilities
- Supervise the Clinical Trial Management and Research Coordination teams.
- Oversee hiring, onboarding, and performance management, while promoting collaboration and professional development.
- Resolve complex study issues requiring strategic operational decisions and provide staff mentorship and structured training.
- 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.
- Oversee site qualification, selection, activation, ongoing management, and remediation.
- Ensure compliance with FDA, ICH/GCP, IRB, and institutional standards.
- Oversee regulatory submissions, continuing reviews, reportable event documentation, safety reporting, and IRB and sponsor correspondence.
- Maintain the Trial Master File and site investigator files in inspection-ready status.
- Monitor study enrollment, safety reporting, and data accuracy.
- Lead audit readiness and serve as the primary operational contact during sponsor, institutional, or regulatory audits.
- Support development and implementation of centralized and risk-based monitoring strategies.
- Support protocol development and review and contribute to informed consent forms, operational workflows, and study-specific procedure manuals.
- Lead development and revision of monitoring plans, data management plans, MOPs/SOPs, core lab manuals, and training materials.
- Oversee EDC and CRF development, validation testing, and user feedback with data management and biostatistics teams.
- Conduct or oversee site qualification, initiation, routine monitoring, and closeout visits.
- Lead Investigator Meetings, Site PI meetings, vendor kickoff sessions, and study milestone reviews.
- 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.
- Oversee vendors, including imaging core labs, EDC/CTMS providers, CROs, and specialty service partners, and ensure their deliverables, timelines, reporting, and quality meet expectations.
- Coordinate with external academic, industry, and consortium partners to support aligned study execution.
- Collaborate with biostatistics and data management teams to support data accuracy, timely query resolution, and database lock.
- Support interim and final data analyses, clinical study reports, abstract submissions, conference presentations, and manuscript development.
- Track and report trial performance metrics to leadership and sponsors.
- Perform other related duties.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
