Clinical Project Manager

4 weeks ago

Slough Berkshire, United Kingdom MSI Pharma Full time

MSI Pharma are looking for a Clinical Project Manager to join a prestigious Biotechnology company based in the UK accountable for leading Clinical Study Teams across Phase 1 studies.

Responsibilities:

  • At the study kick-off meeting, articulate study scope, goals, and expectations of the business to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.
  • Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings.
  • Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments.
  • Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit.
  • Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.
  • Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.
  • Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.

Minimum Education / Qualification:

  • Bachelor's degree or equivalent required (scientific or healthcare discipline preferred).
  • 4-7 years clinical and drug development experience; ideally 3+ years clinical project management experience including leading and managing cross functional teams
  • Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
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