Study Start-Up Senior Manager
hace 4 semanas
Descripción de la empresa A misión da AbbVie é pesquisar e fornecer medicamentos e soluções inovadoras que abordem os principais desafios de saúde atuais e os desafios médicos de amanhã. A Allergan Aesthetics, juntamente com os produtos e serviços do nosso portfólio, visa causar um impacto significativo na vida das pessoas em várias áreas terapêuticas importantes (imunologia, oncologia, neurociência e oftalmologia). Para obter mais informações sobre a AbbVie, visite (somente em inglês). Siga @abbvie no Twitter, Facebook, Instagram, YouTube e LinkedIn Descripción del empleo Sr Manager, Study Start‑Up es responsable de la entrega oportuna, dentro del presupuesto y de alta calidad, de la ejecución de actividades de inicio de estudios clínicos y mantenimiento en toda la región de América Latina. Reporta al Jefe de Región, Gestión de Sitios Clínicos – América Latina y Puerto Rico, y actúa como líder responsable principal de todas las operaciones de inicio y mantenimiento en el país y en los sitios en la región. Key Responsibilities: Serve as the line manager for Country SSU Specialists and Clinical Operations Managers as appropriate, leading talent growth and development initiatives. Oversee resource management, recruitment, performance reviews, and talent development for assigned SSU staff. Provide strategic input related to study start‑up timelines, site profiles, and risk assessments to inform regional and country strategies. Develop and implement country/site activation plans, including risk assessment and mitigation strategies. Maintain country and site intelligence to ensure optimal site activation. Monitor and report start‑up performance metrics for the region. Lead region quality management initiatives with a risk‑based approach. Foster a learning environment by sharing best practices, lessons learned, and driving continuous improvement through analysis of key performance and risk indicators. Manage and mitigate start‑up risks through effective action plans. Ensure audit/inspection readiness and compliance with corporate/divisional policies and global regulatory standards. Collaborate cross‑functionally with Country COMs, GSM organization, Global and Area SSU Directors/Managers. Champion process simplification and enhance agility through regional training, SOPs, and work instruction development. Consolidate lessons learned and integrate them into SSU training. Lead or participate in cross‑functional process improvement initiatives or special projects as needed. Requisitos Qualifications: Bachelor's degree in health care or a scientific field required. Minimum 12 years of clinical research experience, with at least 5 years in study start‑up management preferred. At least 4 years in line management, including recruiting, performance management, talent development, and team mentorship. Demonstrated success in developing and retaining high‑potential staff. Advanced understanding of all roles within the job family. Ability to work independently with minimal oversight. Proven cross‑functional leadership; experience with remote/virtual teams; strong stakeholder influence and alignment. Strong analytical, critical thinking, and decision‑making skills; excellent interpersonal and communication abilities; adaptability to change. Demonstrated successful program execution and multitasking in a fast‑paced environment. Progressive responsibility and accountability in prior roles. Stakeholders: Clinical Development Operation, Global Site Contracting & Purchasing, Supplier Management, Area/Affiliate Regulatory, Clinical Trial Submissions Group, Legal, Safety, OEC, CDC and Global Medical Affairs. Información adicional AbbVie es un empleador que ofrece igualdad de oportunidades y se compromete a operar con integridad, impulsar la innovación, transformar vidas y servir a nuestra comunidad. Empleador que ofrece igualdad de oportunidades, veteranos y discapacitados. #J-18808-Ljbffr
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