Freelance Clinical Project Manager; Rare Disease FTE

Position: Freelance Clinical Project Manager (Rare Disease 0.8 FTE)
Location: Via Milano

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!