Scenario for Managing Clinical Projects

This topic gives one example of how to manage clinical projects. You might manage clinical projects differently, depending on your business model.

This topic includes the following information:

• "Setting Up and Staffing the Project"

• "Managing Tasks, Activities, and Risks"

Setting Up and Staffing the Project

A product manager works for a large CRO (clinical research organization) that has a contract to carry out a clinical trial for a pharmaceutical company. He is responsible for setting up and running the project for a clinical trial.

First, the product manager enters some basic information about the project into Siebel Clinical, and determines the employees that can access the project data by entering them in the project access list.

To optimize the resource assignment, the product manager enters the resource requirements in the team workbook, and then uses Siebel Assignment Manager to help with the staffing. He specifies the roles, skills, competencies, and availability required for the team, and lets Resource Manager find the best candidate for the roles.

For this large project, the CRO might need some subcontractors to complete certain aspects of the project. Because the subcontractors are paid at an hourly rate, the product manager associates the appropriate billing rate list with the project. He also must add employees of the subcontracting company to the subcontractor resource list.

The product manager can add other external contacts and accounts to the project. For example, he can add information about the central laboratory and the primary contact at this laboratory.

Managing Tasks, Activities, and Risks

You can set milestones as tasks or activities. The product manager can create milestones within projects in Siebel Clinical. Each Siebel activity has a budget, and end users update the actual costs of these activities as the project progresses. Periodically, the product manager reviews these project costs, making sure that the project stays within budget. Payments you make to sites for subject activities are rolled up to the project costs.

You document project risks as they arise, and you document the resolution activities to address the risks.