This is the first in a series celebrating key roles in the clinical trials industry.
The contract research organization’s clinical project manager (CPM) does not have a light workload. CPMs plan and direct activities to ensure trials meet objectives and remain in compliance.
They are skilled communicators, keeping many people, including team members, investigators, sponsors, and consultants, on top of study needs.
In many ways, they are the heart of clinical trials. Here are some of the critical areas the CPM must stay on top of:
Prepare and plan
Studies are touched by CPMs at every stage, right from the beginning, including contributing to the development of the study protocol and determining how data will be collected and evaluated.
Keeping the study on track is one of the CPM’s greatest challenges. Many factors conspire to knock studies off track. Delay in study startup is one of the biggest challenges the industry – and therefore, the CPM — faces. To help stay on track, they anticipate and proactively develop contingency plans to handle delays or issues.
CPMs prepare and manage research budgets and monetary disbursements. Money coming in, and money going out — it’s on them.
Resource management and meetings, meetings, meetings
CPMs utilize internal and external resources to conduct their trials and rely heavily on vendor support programs. A CPM can have as many as 10-12 external vendors supporting up to 50 percent of a study. For weeks, months, even years, there can be weekly, biweekly, and monthly meetings with vendors regarding a single study. Staying on top of all these details, with the status and contribution of each vendor, is a daily challenge.
CPMs are key players in the patient recruiting and retention process. They help determine criteria for enrollment, recruitment strategies, and keep track of subject progress throughout the study.
Prepare documents and maintain records
CPMs prepare and maintain study materials, including documents, manuals, and progress reports. This often includes oversight of the trial master file.
Monitor and act
CPMs closely monitor their studies to make sure protocols, SOPs, and GCP/ICH guidelines are followed. They also gather/monitor metrics to evaluate project progress. When problems are identified, the CPM works with relevant parties to see they are resolved.
CPMs are always learning. In order to stay on top of the latest information in trials, CPMs study scientific publications, take part in educational programs, and attend industry conferences. Staying current is a continuous process.
And that isn’t everything…
We realize this is not a complete list! If you are a clinical project manager, we would love to hear some of your experiences regarding your responsibilities and best practices. Please scroll down and enter your thoughts in the comment box.