
1001 - 5000 employés
Fondée en 1999
💼 Conseil
🏥 Santé
🧬 Biotechnologie
Consulting • Healthcare • Biotechnology
CTI Clinical Trial and Consulting Services est une organisation de recherche sous contrat (CRO) à service complet qui offre l'exécution d'essais cliniques, une stratégie réglementaire, des services de laboratoire et bio-analytiques, la génération de preuves du monde réel et la gestion de centres de recherche pour les promoteurs biotechnologiques et pharmaceutiques. Avec une expertise couvrant les études de phase I à IV et des domaines thérapeutiques complexes (y compris les maladies rares, la thérapie cellulaire et génique, l'oncologie, la neurologie et la transplantation), CTI soutient la conception d'études, la gestion de sites, le recrutement de patients, la surveillance, la sécurité/pharmacovigilance, la biométrie et l'assurance qualité. Basée à Covington, KY, l'entreprise met l'accent sur des approches intégrées et centrées sur le patient et sur l'orientation réglementaire mondiale pour accélérer le développement et apporter des thérapies aux patients.
🕒 il y a 2 jours
🗣️🇺🇸🇬🇧 Anglais requis
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1001 - 5000 employés
Fondée en 1999
💼 Conseil
🏥 Santé
🧬 Biotechnologie
Consulting • Healthcare • Biotechnology
CTI Clinical Trial and Consulting Services est une organisation de recherche sous contrat (CRO) à service complet qui offre l'exécution d'essais cliniques, une stratégie réglementaire, des services de laboratoire et bio-analytiques, la génération de preuves du monde réel et la gestion de centres de recherche pour les promoteurs biotechnologiques et pharmaceutiques. Avec une expertise couvrant les études de phase I à IV et des domaines thérapeutiques complexes (y compris les maladies rares, la thérapie cellulaire et génique, l'oncologie, la neurologie et la transplantation), CTI soutient la conception d'études, la gestion de sites, le recrutement de patients, la surveillance, la sécurité/pharmacovigilance, la biométrie et l'assurance qualité. Basée à Covington, KY, l'entreprise met l'accent sur des approches intégrées et centrées sur le patient et sur l'orientation réglementaire mondiale pour accélérer le développement et apporter des thérapies aux patients.
• Lead development, management and oversight of the trial site budgets team • Serve as a high-level operational contact with leadership • Coordinate standardization and best practices for CTI site budget development processes • Provide operational direction, prioritization, coaching, performance management and ongoing optimization • Ensure team deliverables meet timelines, quality standards and business requirements • Identify risks, capacity constraints, bottlenecks and milestones and implement corrective actions • Ensure budgets align with study, sponsor, regulatory and organizational requirements • Simplify, standardize, automate and optimize workflows with Site Activation and cross-functional teams • Establish and maintain standardized budget processes, tools, templates and operating procedures • Monitor operational data and trends and provide actionable insights to senior leaders • Lead resolution and escalation of complex or high-risk budget issues • Drive adoption of organizational change, processes, systems and ways of working • Share lessons learned with the Site Activation team and improve budget processes • Plan, implement, facilitate and evaluate assigned clinical trials from planning through analysis • Serve as primary senior interface with CTI executive management and sponsors • Manage client relationships and resolve or escalate trial issues • Ensure compliance with ICH, GCP, regulatory guidelines and trial procedures • Oversee CPM management of budgeted hours, project budgets, milestones and corrective measures • Review scope of work against contractual agreements and assist with scope changes and contract amendments • Supervise, mentor and evaluate CPMs and direct reports • Oversee recruitment, resourcing and management of site budget/payment specialists • Establish training programs for site budget and payment services staff • Provide high-level review and oversight of site budget development for RFPs
• At least 10 years of clinical research experience and/or experience in CTI clinical project management • Clear and thorough understanding of global trial management processes and the operation of all clinical trial functional areas • Bachelor’s Degree or equivalent in allied health fields such as nursing, pharmacy or health science • Experience in management of clinical trials • Thorough and current understanding of at least one therapeutic area for which CTI is contracted for clinical projects • Knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures
• Structured mentoring program • Leadership development courses • Ongoing education and training opportunities • Tuition reimbursement • Generous health benefits • Vacation packages • Hybrid work opportunities • Paid parental leave • CTI Cares community and global giving opportunities
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