Study Start-Up Senior Manager (Latam)
AbbVie
Descripción de la empresa
A 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 LinkedIn
Descripción del empleo
Your 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/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.
+ 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 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.
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