Local Study Associate Director

Experteer Overview

As Local Study Associate Director, you drive the country-level execution of committed study components within time, budget, and quality targets. You lead Local Study Teams to ensure adherence to ICH-GCP and local regulations while coordinating site identification, setup, monitoring, and documentation. You may perform site monitoring to support a flexible capacity model. This role blends leadership, regulatory focus, and site-level operations to deliver reliable data and compliant trials.

Retribuzione / Benefits

• Own study commitments for the country and ensure timely data delivery at required quality
• Lead Local Study Team(s) comprising CRA(s) and CSA(s) to achieve study goals
• Coordinate site selection, Site Quality Risk Assessments, and Site Qualification Visits
• Oversee regulatory submissions to EC/IRB and Regulatory Authority in line with local regulations
• Manage country-level financials and country Master CSA/MICF documentation and amendments
• Set up and maintain CTMS and local websites per local laws
• Oversee monitoring activities from activation to closure and guide monitors on study matters
• Identify risks and coordinate resolution of complex study issues
• Foster cross-functional collaboration and build relationships with sites, investigators, and stakeholders
• Ensure readiness of trial documents for eTMF archiving and lead local audits/regulatory inspections
• Contribute to risk management planning and patient recruitment strategy
• Communicate progress to Global Study leadership and Line Managers
• Ensure compliance with Sponsor Ethics, company policies, and SHE policies
• Collaborate with Medical Affairs and support SMM initiatives
• Provide input to process improvements and local policy adherence
• Location-based requirement per sponsor

Responsabilità

• Bachelor degree in related discipline, preferably life science
• Minimum 3 years of Development Operations or related fields (CRA/Sr CRA)
• Good knowledge of ICH-GCP and local regulations
• Proven leadership of cross-functional teams to deliver trials on time, within budget and with quality
• Medical knowledge across Oncology, Rare Diseases, cardiology, hematology, CVRM Therapeutic Areas
• Strong understanding of Drug Development Process and Clinical Study Process
• Excellent project management and multitasking abilities
• Strong English and Italian spoken/written skills
• Ability to learn and adapt to IT systems
• Willingness to travel nationally and internationally
• Location-based requirement per sponsor