A Clinical Project Manager (CPM) is a person who has the overall responsibility for the successful initiation, planning, design, execution, monitoring, and closure of a project. The CPM can be appointed for the entire project, for selected parts of the project or appointed as a Sponsor Oversight representative As a sponsor, it’s crucial to have one point of contact for our entire team and have the support of an experienced CPM with the expertise to offer insightful solutions to challenges and obstacles, while ensuring that your project is delivered on time with quality.
Clinical project management activities include:
- Collaboration with all stakeholders in the clinical project
- Ensuring all stakeholders are well-informed throughout the study
- Development of clinical project plans and timelines
- Establishing the necessary documentation for regulatory and ethics committee approvals
- Coordinating the preparation of study documents such as the study protocol/report, informed consent and patient information, case report forms, and study files.
- Site selection, investigator meetings, as well as site training and documentation
- Continuous, proactive risk management
- Vendor oversight
- Implementation of the Electronic Data Capture (EDC) system and trial master file
- Coordination of clean file and study closure activities
- Sponsor oversight tasks for a clinical project
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