Local Study Associate Director

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b1kxs

Experteer Overview

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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 xlwpduy 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b1kxs