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Clinical Research Manager

Insight Global

Clinical Research ManagerInsight 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. The 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.Responsibilities:Lead and manage day-to-day clinical research operations across multiple active studiesSupervise Clinical Research Coordinators and other research personnel while providing leadership, mentorship, and performance managementCoordinate with multidisciplinary teams including physicians, pharmacists, infusion nurses, research coordinators, and support staffOversee all aspects of trial execution, including patient recruitment, screening, enrollment, informed consent, treatment coordination, and retentionEnsure studies are conducted in compliance with sponsor requirements, FDA regulations, ICH/GCP guidelines, and internal SOPsEvaluate study feasibility and support study startup activitiesDevelop, review, negotiate, and manage study budgets and clinical trial agreementsMonitor study timelines, enrollment goals, budgets, and overall site performanceResolve study-related billing concerns, sponsor payment issues, contract discrepancies, and financial reconciliation mattersAssess and troubleshoot clinical research workflows within electronic health record systemsServe as a primary liaison between investigators, sponsors, CROs, regulatory agencies, and internal stakeholdersConduct departmental meetings and provide strategic direction for research operationsEvaluate and improve departmental workflows to increase study efficiency and patient enrollmentManage performance expectations and reviews for research personnelMaintain involvement in study coordination activities while providing department-wide leadership

Vacancy posted 2 hours ago
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