EPM Scientific are currently partnered with a Biotechnology company who are seeking a Freelance Clinical Project Manager to support their Rare Disease trials in Italy. See a short summary below:
Contract Conditions:
* Start date: ASAP
* Location: Italy
* Contract: 0.8 - 1 FTE, 12-Month Contract
* Project: Rare Neuromusclar Disease - Phase 2 Trial
Key Responsibilities
* Lead and manage global Phase II-III clinical trials across Rare Disease indications
* Oversee cross-functional teams including biometrics, regulatory affairs, medical writing, and pharmacovigilance to ensure seamless trial execution.
* Develop and maintain project timelines, budgets, and risk mitigation strategies.
* Serve as the primary point of contact for sponsors, vendors, and internal stakeholders.
* Ensure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements.
* Utilize AI-enabled tools and platforms to optimize trial design and operational efficiency.
* Contribute to business operations including budgeting, forecasting, and resource planning.
* Mentor junior team members and foster a culture of excellence and innovation.
Qualifications
* Minimum 10 years of experience in clinical research, with at least 6 years as a Clinical Project Manager.
* Must have direct experience managing Rare Disease studies.
* Experience across multiple phases, preferably Phase II-III.
* Global trial management experience is essential.
* Strong understanding of drug development processes and clinical trial regulations.
* Valid and current GCP certification required.
* Solid knowledge of local regulatory requirements in the EU.
* Proven experience in budgeting and business operations related to clinical project management.
* Excellent communication in English, leadership, and problem-solving skills.
If you or someone you know fits this experience and shows interest, we'd love to speak with you!