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.
