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.
