Head of Multi-Site Clinical Trial Operations

Cardiovascular Associates of America; United States; Remote; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Cardiovascular Associates of America is seeking a Director of Research Operations to lead the day-to-day operational execution across a multi-site clinical trials portfolio in the United States.

You will translate strategy into measurable plans, build scalable processes, oversee startup, enrollment, and delivery, and develop a high-performing team while maintaining rigorous adherence to GCP and sponsor expectations.

Qualifikationen

• Extensive clinical research experience with progressive responsibility.
• Experience overseeing clinical trial execution across multiple studies/sites.
• Strong operational knowledge of study startup, regulatory processes, recruitment and enrollment, trial conduct, and closeout.
• Experience leading teams and coordinating work across multiple functional areas.
• Strong understanding of Good Clinical Practice (GCP) and sponsor-supported clinical trial operations.
• Ability to interpret operational data and use it to drive decisions and performance improvement.

Aufgaben

• Own the operational execution of the clinical trials portfolio from study award through closeout.
• Translate organizational priorities into clear operational plans, responsibilities, timelines, and performance expectations.
• Create consistent operating practices across centralized research functions and participating research sites.
• Maintain visibility into the health of the clinical trial portfolio, including startup progress, enrollment performance, operational milestones, staffing and workload, and significant risks or barriers.
• Ensure issues are identified early, assigned to the appropriate owner, escalated when necessary, and followed through to resolution.
• Drive efficient movement of studies from award through site activation.
• Ensure coordination of regulatory activities, site readiness, systems setup, training, investigator preparation, operational planning, and other startup requirements.
• Establish measurable startup expectations and monitor studies against those expectations.
• Identify recurring causes of activation delays and implement process improvements to address them.
• Ensure effective operational processes for identifying, screening, and enrolling appropriate research participants.
• Coordinate centralized recruitment resources with site-based recruitment and clinical-practice workflows.
• Strengthen integration of clinical research into routine patient care so that investigators and clinical teams can effectively identify potential participants.
• Establish visibility into recruitment funnels and enrollment performance and ensure underperforming studies have actionable recruitment plans.
• Drive follow-through and accountability for enrollment initiatives.
• Create consistent project-management standards across active studies.
• Ensure studies have appropriate operational plans, timelines, meeting structures, deliverables, action-item tracking, escalation pathways, and communication processes.
• Establish clear ownership of study activities and ensure commitments to sponsors, investigators, sites, and internal stakeholders are tracked through completion.
• Develop processes that allow leadership to identify studies requiring intervention before significant milestones are missed.
• Ensure regulatory activities are effectively integrated into startup and ongoing study operations.
• Maintain efficient processes for submissions, essential-document management, investigator documentation, amendments, continuing reviews, and closeout activities.
• Ensure regulatory workload and timelines are visible within overall study planning.
• Partner with quality and compliance leadership to address operational findings and ensure corrective actions are translated into sustainable operational practices.
• Ensure research technology supports efficient trial execution across the network.
• Drive effective adoption and utilization of clinical trial management, electronic source, electronic regulatory, recruitment, and other research platforms.
• Identify workflow or technology barriers that create unnecessary administrative burden and lead efforts to improve them.
• Ensure research staff receive appropriate onboarding, systems training, role-based training, and ongoing operational education.
• Identify opportunities to appropriately use technology, automation, data, and artificial intelligence to improve research operations.
• Develop and maintain meaningful operational metrics related to study startup, enrollment, trial performance, site performance, staffing, workload, and delivery.
• Use data to identify trends, anticipate operational needs, and guide resource allocation.
• Establish regular operating reviews that move beyond reporting information to identifying decisions, owners, actions, and deadlines.
• Provide executive research leadership with concise, reliable visibility into operational performance, significant risks, resource requirements, and issues requiring executive intervention.
• Build a high-performing, collaborative research operations organization with clear responsibilities and accountability.
• Ensure functional teams operate as an integrated clinical trials organization rather than as independent operational silos.
• Develop leaders and team members who can independently solve problems, make appropriate decisions, and take ownership of outcomes.
• Evaluate workload and staffing requirements as the portfolio grows and recommend resource changes based on operational demand.
• Create a culture characterized by ownership, responsiveness, collaboration, transparency, and continuous improvement.

Kenntnisse

Clinical research operations

Leadership

Study startup

Regulatory processes

Recruitment & enrollment

GCP knowledge

Data interpretation

Cross-functional collaboration

Tools

Clinical trial management systems

Electronic data systems

Jobbeschreibung

Cardiovascular Associates of America is seeking a Director of Research Operations to lead the day-to-day operational execution across a multi-site clinical trials portfolio in the United States.

You will translate strategy into measurable plans, build scalable processes, oversee startup, enrollment, and delivery, and develop a high-performing team while maintaining rigorous adherence to GCP and sponsor expectations.