PEPM Scientific are currently partnered with a Biotechnology company who are seeking a bFreelance Clinical Project Manager /b to support their Rare Disease trials in Italy. See a short summary below: /ppbContract Conditions: /b /pulliStart date: ASAP /liliLocation: Italy /liliContract: 0.8 - 1 FTE, 12-Month Contract /liliProject: Rare Neuromusclar Disease - Phase 2 Trial /li /ulpbr/ppbr/ppbKey Responsibilities /b /pulliLead and manage global Phase II-III clinical trials across Rare Disease indications /liliOversee cross-functional teams including biometrics, regulatory affairs, medical writing, and pharmacovigilance to ensure seamless trial execution. /liliDevelop and maintain project timelines, budgets, and risk mitigation strategies. /liliServe as the primary point of contact for sponsors, vendors, and internal stakeholders. /liliEnsure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements. /liliUtilize AI-enabled tools and platforms to optimize trial design and operational efficiency. /liliContribute to business operations including budgeting, forecasting, and resource planning. /liliMentor junior team members and foster a culture of excellence and innovation. /li /ulpbr/ppbr/ppbQualifications /b /pulliMinimum 10 years of experience in clinical research, with at least 6 years as a Clinical Project Manager. /liliMust have direct experience managing Rare Disease studies. /liliExperience across multiple phases, preferably Phase II-III. /liliGlobal trial management experience is essential. /liliStrong understanding of drug development processes and clinical trial regulations. /liliValid and current GCP certification required. /liliSolid knowledge of local regulatory requirements in the EU. /liliProven experience in budgeting and business operations related to clinical project management. /liliExcellent communication in English, leadership, and problem-solving skills. /li /ulpbr/ppbr/ppIf you or someone you know fits this experience and shows interest, we'd love to speak with you! /p