Clinical Research Manager

Required Skills & Experience
• Bachelor's Degree\n• 5 years of experience in clinical research\n• Minimum 2 years of leadership or management experience within clinical research\n• Strong knowledge of ICH/GCP guidelines and FDA regulations governing clinical research\n• Experience overseeing clinical trial operations from startup through closeout\n• Experience with patient recruitment, enrollment, consent, and study management\n• Budget development, financial oversight, and contract negotiation experience\n• Familiarity with electronic medical records (EMR/EHR) systems\n• Experience using electronic or remote data capture systems\n• Strong leadership, communication, and organizational skills\n• Ability to manage multiple studies and priorities simultaneously

Nice to Have Skills & Experience
• Nursing degree\n• ACRP or SOCRA Certification\n• Experience managing Clinical Research Coordinators and research staff\n• Experience working directly with sponsors, CROs, and Principal Investigators

Job Description

Insight Global is seeking a Clinical Research Manager to oversee the day-to-day execution of clinical research operations across multiple studies and therapeutic areas. This individual will report directly to executive leadership and serve as the operational leader for the research department, ensuring studies are conducted in accordance with sponsor protocols, FDA regulations, ICH/GCP guidelines, and organizational standards.\nThe Clinical Research Manager will partner closely with Principal Investigators, sponsors, CROs, pharmacists, infusion nurses, Clinical Research Coordinators, and support staff to ensure successful study execution, patient safety, regulatory compliance, and financial performance. This role combines clinical research leadership, staff management, operational oversight, regulatory compliance, and financial stewardship.\n\nResponsibilities:\n• Lead and manage day-to-day clinical research operations across multiple active studies\n• Supervise Clinical Research Coordinators and other research personnel while providing leadership, mentorship, and performance management\n• Coordinate with multidisciplinary teams including physicians, pharmacists, infusion nurses, research coordinators, and support staff\n• Oversee all aspects of trial execution, including patient recruitment, screening, enrollment, informed consent, treatment coordination, and retention\n• Ensure studies are conducted in compliance with sponsor requirements, FDA regulations, ICH/GCP guidelines, and internal SOPs\n• Evaluate study feasibility and support study startup activities\n• Develop, review, negotiate, and manage study budgets and clinical trial agreements\n• Monitor study timelines, enrollment goals, budgets, and overall site performance\n• Resolve study-related billing concerns, sponsor payment issues, contract discrepancies, and financial reconciliation matters\n• Assess and troubleshoot clinical research workflows within electronic health record systems\n• Serve as a primary liaison between investigators, sponsors, CROs, regulatory agencies, and internal stakeholders\t\n• Conduct departmental meetings and provide strategic direction for research operations\n• Evaluate and improve departmental workflows to increase study efficiency and patient enrollment\n• Manage performance expectations and reviews for research personnel\n• Maintain involvement in study coordination activities while providing department-wide leadership