01 ago - Bardi
Experteer Italy
Experteer Overview In this role you drive country?level CAR?T study delivery, translating complex strategies into actionable operational plans. You lead a local study team, ensuring compliant, timely activation and strong site performance in a fast?moving, cross?functional environment. You partner with monitoring, regulatory, medical, data and quality to keep studies inspection?ready and data integrity high. You shape execution plans to accelerate patient access and strengthen site relationships, balancing speed with disciplined governance. This position places you at the heart of delivering transformative therapies to patients, with a clear impact on timelines, quality and collaboration. Retribuzione / Benefits * Lead the Local Study Team, set operating rhythm, optimize performance within budget and ensure governance and compliance * Translate protocol into country execution plans; develop monitoring strategies; coordinate site identification and timely submissions * Perform country feasibility assessments, engage investigators and sites, shape enrollment and study delivery plans * Conduct co?monitoring, review monitoring outputs,
oversee audits and drive CAPAs to maintain inspection?readiness * Maintain complete study documentation and ensure systems are current for regulatory readiness and archiving * Collaborate with CRAs, Investigators and Regulatory Affairs; communicate progress and risks to stakeholders * Onboard and coach new team members; drive process improvements to reduce cycle times and scale best practices across studies * Contribute to regional initiatives and harmonize ways of working beyond a single study Responsabilità * Proven ability to lead a Local Study Team and manage budgets * Experience delivering studies with monitoring plans, site selection and timely documentation submissions * Experience co?monitoring, monitoring reports review and audit oversight * Ensured document completeness and archiving readiness * Strong collaboration with CRAs, Investigators and Regulatory Affairs with proactive updates * Experience training new team members and driving process improvements * Commitment to company values and supporting regional initiatives Requisiti fondamentali * annual target bonus * Participation Premio * Wellbeing benefits (welfare, insurance, psychological support) * Sales incentives governed by company policies * Full?time permanent contract * Salary: 64,****** to 96,****** per annum #J-*****-Ljbffr
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