Senior Study Manager

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

The Senior Study Manager (SSM) is responsible for the end-to-end operational management primarily for early-phase clinical trials (Phase I – including FIH and II), but also able to manage late-phase studies (Phase IIb, III, and IV) and observational studies. The role ensures studies are delivered on time, within budget, and in compliance with regulatory requirements, GCP, and company SOPs. Le seguenti informazioni forniscono una panoramica delle competenze, delle qualità e delle qualifiche necessarie per questo ruolo. Key Responsibilities Study Planning & Start‐Up Lead operational planning, including develop and manage clinical study timelines. Co‐lead protocol development and operational feasibility assessments. Oversee study start‐up activities, including site selection, feasibility, and vendor onboarding. Study Execution Provide day‐to‐day operational leadership for assigned clinical trials, including review and approval of key study documents. Manage CROs, vendors, and clinical sites to ensure quality and timelines. Track study milestones, recruitment, and data quality.



Assess performance metrics. Identify and mitigate operational risks and issues. Vendor & CRO Management Select and manage external vendors (CROs, central labs, imaging vendors, etc.). Support contracts revision and budget definition. Ensure vendor deliverables meet study expectations. Data & Reporting Monitor data quality and cleaning activities. Support database lock and clinical study report (CSR) preparation. Quality & Compliance Ensure studies comply with: ICH‐GCP guidelines Regulatory requirements Company SOPs Support inspection readiness and audits. Cross‐Functional Collaboration Act as the primary operational contact for study teams. Coordinate with: Clinical Development Data Management Biostatistics Regulatory Affairs Pharmacovigilance Clinical Supply Present periodic study status updates to internal governance meetings. Must‐have Education: master's degree in life sciences, pharmacy, or

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