Senior Local Study Lead - Oncology (Mexico)

ThermoFisher Scientific; United States; Remote; USD 150,000 - 230,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Local Study Associate Director to lead country-level Local Study Teams and ensure timely delivery of data for clinical studies in accordance with ICH-GCP and local regulations.

The role includes site selection and qualification, coordination with regulatory affairs, and monitoring through study closure, while managing budgets and collaboration with global stakeholders to drive recruitment and quality.

Qualifications

• Experience leading study teams and coordinating cross-functional stakeholders.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Ability to manage budgets, timelines and document control for clinical studies.

Responsibilities

• Lead Local Study Team(s) to deliver study commitments at country level.
• Coordinate site identification, qualification, start-up, monitoring and closure.
• Ensure timely submissions to EC/IRB and Regulatory Authority per local rules.
• Maintain study budgets and MSA/fSMA documents in the clinical system.
• Oversee monitoring activities from site activation to study closure.
• Collaborate with Foreign/Global teams and National investigators on recruitment.
• Ensure eTMF completeness and documentation readiness for inspections.

Job description

Thermo Fisher Scientific is seeking a Local Study Associate Director to lead country-level Local Study Teams and ensure timely delivery of data for clinical studies in accordance with ICH-GCP and local regulations.

The role includes site selection and qualification, coordination with regulatory affairs, and monitoring through study closure, while managing budgets and collaboration with global stakeholders to drive recruitment and quality.