Study Start-Up Senior Manager (Latam)

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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.

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.

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.