Clinical Trials Manager - Center for Interventional Cardiovascular Research & Clinical Trials
About The Position
The Clinical Trial Manager provides leadership and oversight for planning, conducting, and managing clinical trials within the Center for Interventional Cardiovascular Research & Clinical Trials. The role ensures efficient, high-quality 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 strategic research goals, and implements best practices in trial management, monitoring, vendor oversight, data quality, and regulatory compliance across multiple studies. The Manager supervises clinical trial management and research coordination teams; oversees trial operations, regulatory and quality activities, study start-up and conduct, budgets and resources, vendor and stakeholder relationships, and data and reporting. The position also supports protocol development, monitoring strategy, audit readiness, study analysis, and dissemination of research findings.
Requirements
- Bachelor’s degree in Biology, Public Health, or a related scientific or health field.
- 4–5 years of research experience with exposure to clinical trials.
- 1 year in a management or leadership role.
Nice To Haves
- Master’s degree preferred.
- Experience in cardiovascular research or interventional clinical trials strongly preferred.
Responsibilities
- Supervise the Clinical Trial Management and Research Coordination teams, including hiring, onboarding, performance management, mentorship, and staff training.
- Serve as the operational escalation point for complex study issues requiring strategic resolution.
- 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 communications among investigators, sponsors, and institutional departments.
- Oversee site qualification, selection, activation, ongoing management, remediation, monitoring, and closeout.
- Ensure compliance with FDA, ICH/GCP, IRB, and institutional standards.
- Oversee regulatory submissions, continuing reviews, reportable event documentation, safety reporting, and correspondence with IRBs and sponsors.
- Maintain Trial Master Files 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 in collaboration with data management and biostatistics.
- 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 variances, and recommend resource adjustments.
- Oversee vendor performance and ensure deliverables, timelines, reporting, and quality expectations are met.
- Coordinate with external academic, industry, and consortium partners to align study execution.
- 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, abstracts, 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
