Local Study Associate Director

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7aeuz9

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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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7aeuz9