Study Start-Up Sr Manager, (Latin America)

Allergan Aesthetics; São Paulo; Presencial; BRL 160.000 - 200.000; Tempo integral

Resumo da oferta

A global biopharmaceutical company seeks a Sr Manager, Study Start-Up to oversee clinical study start-up and maintenance across Latin America. The ideal candidate has a Bachelor's degree in health care or a scientific field, with at least 12 years of clinical research experience, including 5 years in study start-up management. Strong leadership, analytical skills, and knowledge of ICH/GCP are essential for ensuring compliance and managing site operations.

Qualificações

• Minimum 12 years of clinical research experience with 5 years in study start-up management preferred.
• Demonstrated success in developing and retaining high-potential staff.
• Advanced working knowledge of ICH, GCP, and the global regulatory environment.

Responsabilidades

• Oversee resource management, recruitment, and performance reviews for SSU staff.
• Develop and implement country/site activation plans, including risk assessment.
• Ensure audit/inspection readiness and compliance with corporate policies.

Conhecimentos

Clinical research experience

Line management

Analytical skills

Communication abilities

Decision-making skills

Adaptability to change

Formação académica

Bachelor’s degree in health care or scientific field

Descrição da oferta de emprego

Company Description

AbbVie mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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.

Pre-requirements

• 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.>

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html