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

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📌 Local Study Associate Director (Lombardia)
🏢 Experteer Italy
📍 Lombardia