Clinical Project Manager

3 giorni fa

Milano, Lombardia, Italia EPM Scientific A tempo pieno

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: 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

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