Clinical Project Manager (CPM) - Belgium (Remote) - Global Pharma
Start Date: ASAP
Interviews from: 26th January 2023
Responsible for leading one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across internal and CRO/Phase 1 Unit teams.
- 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.
If you are interested, then please apply now! If you would like more information, then kindly drop me an email.