Clinical Project Lead

4 weeks ago


Slough, Slough, United Kingdom MSI Pharma Full time
Job Title: Clinical Project Manager

MSI Pharma is seeking a highly skilled Clinical Project Manager to lead Clinical Study Teams across Phase 1 studies.

Key Responsibilities:
  • Develop and articulate study scope, goals, and expectations to the CRO/Phase 1 Unit, ensuring timely access to bioanalytical and/or safety data for review meetings.
  • Create detailed planning of study timelines, defining critical path, and enabling seamless access to data.
  • Ensure scope changes are tracked, endorsed, and reflected in contract amendments before implementation.
  • Review and challenge CRO/Phase 1 Unit strategy and plans, if necessary.
  • Demonstrate robust oversight of sponsor delegated activities through regular review of KPIs, metrics, and deliverables, focusing on trial subject safety, data quality, and critical activities.
  • Establish and maintain a Risk Mitigation Plan at the beginning of the study.
Requirements:
  • Bachelor's degree or equivalent in a scientific or healthcare discipline.
  • Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.

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