Study Start-Up Senior Manager (Latam)

Descripción de la empresaA missão 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 www.abbvie.com (somente em inglês). Siga @abbvie no Twitter, Facebook, Instagram, YouTube e LinkedInDescripción del empleoYour Role:The Sr Manager, Study Start-Up is responsible for the timely, within-budget, and high-quality delivery and execution of clinical study start-up and maintenance activities across the Latin America region. Reporting to the Region Head, Clinical Site Management - Latin America and Puerto Rico, this role acts as the primary accountable leader for all country and site start-up and maintenance operations in the region.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/ManagersChampion 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.RequisitosQualifications: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.Advanced working knowledge of ICH, GCP, and the global regulatory environment.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 adicionalAbbVie 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.