Clinical Trials Management

Management Structure

Clear, candid, and frequent communications between the client and a contract research organization (CRO) significantly contribute to the success of a study.

To facilitate such communications, Westat uses a flat management structure that

  • Increases our flexibility in responding to our clients’ needs
  • Ensures our clients have quick access to decisionmakers
  • Enables our project managers to make day-to-day management decisions

Each project is assigned a Corporate Officer to whom the project manager has ready access. Westat’s project managers maintain an open flow of communication among all Westat team members and, most importantly, our clients.

Manager Responsibilities

Each study has a project manager who is tasked with clinical trials management. The needs of our clients determine the responsibilities of the project manager.

These responsibilities may include

  • Serving as the primary liaison with the client
  • Establishing procedures for tracking Westat’s study milestones, deliverables, and budget and ensuring all are met
  • Coordinating all project team activities via constant communication with the functional area leaders (data management, regulatory affairs, clinical logistics, information technology, analytic programming, biostatistical analysis)
  • Developing a project management plan in accordance with Westat’s standard operating procedures (SOPs) and ensuring all Westat project team members are trained on the plan
  • Preparing regular study progress reports for the client

Westat has SOPs for all clinical trial management and execution procedures typically included in a CRO’s responsibilities.

Manager Experience and Training

Westat’s project managers are experienced in all aspects of clinical trials management. They bring considerable functional knowledge to project management through their experience in other areas, including data management, and as clinical research associates.

Westat’s project managers complete an in-house project management training program. They also undergo additional training via industry-accepted training programs and in-service seminars.

Project managers continually review the status of all items to ensure that the tasks are progressing as planned. Project managers identify potential risks and prepare contingency plans for critical items. When a problem arises, the project manager will communicate the problem to both the Corporate Officer and client along with a proposed solution for bringing the project back on track.

The project manager provides technical advice and expertise to the team so that decisions can be reached quickly. All deliverables are reviewed by the project manager for quality, accuracy, and completeness prior to being submitted to the client.