Study Start-Up Senior Manager (Latam)
Share
Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 :
Qualifications:
- Bachelors 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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
