Clinical Project Manager (Rare Disease)

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!