Clinical Research Operations Lead: Multi-Study Compliance

Insight Global; Dallas (TX); In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Insight Global seeks a Clinical Research Manager to oversee day-to-day clinical operations across multiple studies, working with Principal Investigators, sponsors, CROs, pharmacists, infusion nurses, and coordinators to ensure patient safety, regulatory compliance, and financial performance.

You will lead a team of Clinical Research Coordinators, manage budgets and contracts, and ensure startup through closeout execution aligned with sponsor requirements and internal SOPs.

Competenze

• 5 years of experience in clinical research
• Minimum 2 years of leadership or management experience within clinical research
• Strong knowledge of ICH/GCP guidelines and FDA regulations governing clinical research
• Experience overseeing clinical trial operations from startup through closeout
• Experience with patient recruitment, enrollment, consent, and study management

Mansioni

• Lead and manage day-to-day clinical research operations across multiple active studies
• Supervise Clinical Research Coordinators and other research personnel while providing leadership, mentorship, and performance management
• Coordinate with multidisciplinary teams including physicians, pharmacists, infusion nurses, research coordinators, and support staff
• Oversee all aspects of trial execution, including patient recruitment, screening, enrollment, informed consent, treatment coordination, and retention
• Ensure studies are conducted in compliance with sponsor requirements, FDA regulations, ICH/GCP guidelines, and internal SOPs
• Evaluate study feasibility and support study startup activities
• Develop, review, negotiate, and manage study budgets and clinical trial agreements
• Monitor study timelines, enrollment goals, budgets, and overall site performance
• Resolve study-related billing concerns, sponsor payment issues, contract discrepancies, and financial reconciliation matters
• Assess and troubleshoot clinical research workflows within electronic health record systems
• Serve as a primary liaison between investigators, sponsors, CROs, regulatory agencies, and internal stakeholders
• Conduct departmental meetings and provide strategic direction for research operations
• Evaluate and improve departmental workflows to increase study efficiency and patient enrollment
• Manage performance expectations and reviews for research personnel
• Maintain involvement in study coordination activities while providing department-wide leadership

Conoscenze

Leadership

Regulatory knowledge

Cross-functional collaboration

Project oversight

Communication

Formazione

Bachelor's Degree

Nursing degree

Descrizione del lavoro

Insight Global seeks a Clinical Research Manager to oversee day-to-day clinical operations across multiple studies, working with Principal Investigators, sponsors, CROs, pharmacists, infusion nurses, and coordinators to ensure patient safety, regulatory compliance, and financial performance.

You will lead a team of Clinical Research Coordinators, manage budgets and contracts, and ensure startup through closeout execution aligned with sponsor requirements and internal SOPs.