Associate Clinical Manager, CTC Hub

🕒 4 dias atrás

🇲🇽 México – Remoto

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👔 Gerente

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Oversee daily line management for assigned clinical operations staff • Provide coaching, development support, resourcing, alignment, training, and professional development • Collaborate with senior management and executive staff on strategic planning and business development • Manage induction and orientation programs for new employees • Maintain staff CVs, training records, position profiles, and experience profiles • Support local resourcing and project/functional lead activities • Escalate issues affecting project deliverables • Deliver training on WPDs, SOPs, local requirements, and clinical operations topics • Identify training gaps and support training program development • Participate in process improvement initiatives • Facilitate risk-based monitoring • Alert management to quality issues, request QA audits, and support audit responses • Review CTMS, Preclarus, and Clarity systems to evaluate metrics, KPIs, and project status • Evaluate staff work and conduct remote or on-site PAVs • Manage interviewing, selection, job descriptions, development, goal setting, performance management, coaching, counseling, and separations • Review and approve time records, expense reports, leave requests, and overtime • Manage client CTOS and site records coordination • Plan, distribute, collect, and quality-check site records through the Site Collaboration tool • Coordinate clinical trial regulatory tasks, materials, documentation, submissions, supplies, reporting, and stakeholder communication • Maintain clinical systems and trial data tracking • Support TMF completion and OMP milestones

🎯 Requisitos

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 0 to 5 years • 1+ year of leadership responsibility • Secondary education in Business Administration or equivalent • 2 years of experience for Clinical Trial Operations Specialist responsibilities • 0-1 year of experience for Site Records Coordinator responsibilities • Understanding of Clinical Operations Landscape • Understanding of Trial Master File • Understanding of TMF Reference Model • Understanding of Good Clinical Practice • Good Documentation Practice • Site Collaboration • Understanding of tools and systems • Understanding of CTMS • Communication and stakeholder management • Ability to travel domestically and internationally and frequently drive to site locations

🏖️ Benefícios

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace

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