Entry Guidelines and Judging Criteria
This category is designed to challenge experienced Clinical Project Managers on their understanding of the role of the Project Manager in Clinical Research, from study plan design to implementation.
Suitable for Clinical Project Managers with at least 3 years’ experience in a CRO, Biotech or Pharma or Medical Device setting. Roles that Project Managers may be engaged in include Local/Global Study Manager, Clinical Study Leader, Clinical Project Manager, Clinical Trial Manager or Clinical Operations Leader.
- Finalists will be invited to take part in a category-specific case-study challenge developed by an independent expert panel.
- Finalists will be presented with the challenge on the finals day – and given a set period of time for preparation (usually 1 hour) – before delivering their presentation to a judging panel of senior industry clinical researchers.
- Finalists will be questioned on key Project Manager competencies to assess their understanding of them in relation to their role.
Specific scoring criteria are utilised alongside each year’s unique case-study / challenge. Project Manager finalists will be expected to demonstrate the following core project management skills:
- Assimilate clinical information in the challenge
- Develop a detailed project management plan
- Knowledge and application of ICH-GCP and relevant regulatory guidances
- Knowledge and application of clinical monitoring approaches
- Develop clinical project management solutions and implementation plans
- Demonstrate ability to identify and deploy novel clinical trial technologies
- Approaches to tracking and monitoring implementation of the project plan