In the Clinical Research industry we hear a lot about Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). The Clinical Trial Manager (CTM) role receives less attention, however, a CTM is a key player essential to every clinical trial!
A knowledgeable, skilled CTM truly benefits their employer, their colleagues, and their clinical trial. But what does a Clinical Trial Manager actually do?
What is a Clinical Trial Manager?
A Clinical Trial Manager is typically employed by a Clinical Research Organization (CRO) or Pharmaceutical Company (aka Study Sponsor) and plays a vital role in the management of clinical trials. The CTM leads all of the activities that are part of a research study with a paramount goal of keeping the study on track so that it is completed on time, within budget, and yields high-quality results.
As leaders of a Clinical Research Team, CTMs are accountable for the success of their studies.
While responsibilities may differ depending on the employer, CTMs typically oversee day to day clinical activities and drive study timelines. They work directly with their study assigned Clinical Research Associates by reviewing monitoring visit reports, answering study-related questions, and as an escalation point if there are issues.
Clinical Trial Managers also work directly with the Study Sponsor, cross-functionally with other teams such as Data Management, engage with Investigators and Study Coordinators, and manage study vendors. These are just a few of the typical CTM responsibilities.
Different from other members of a Clinical Research Team, CTMs are involved in each stage of a trial, from Start-Up to Maintenance to Close-Out.
What are the education and experience requirements needed to become a CTM?
The hiring company will always have specific requirements for someone who is taking on the Clinical Trial Manager role. The job description is the best place to learn more information about the ideal background an organization wants to find in the person assuming the CTM position.
While education requirements may range from potential CTM candidates having a 4-year Bachelor’s degree in nursing, life sciences, or another related field to a Master’s Degree, the expectation is for Clinical Trial Managers to understand how trials run before they start. Prior clinical trial experience can help.
Experienced Clinical Research Associates or Clinical Trial Assistants often move to the CTM role as a natural career progression. Since CRAs and CTAs work so closely with the CTM, they have the opportunity to observe the Clinical Trial Manager role. A highly-rated, successful CRA or CTA is likely a strong candidate for a promote-from-within opportunity, but these are not the only career progression paths.
What is a CTM responsible for in each stage?
Clinical Trial Managers are heavily involved in each stage of a clinical study. They typically oversee the daily activities and operations of a study, which generally includes planning, implementation, tracking, and administration. Examples of some CTM job duties for each stage are listed below.
During Start-Up, the CTM works on study timelines, key study document finalization, site feasibility, site selection, vendor set up, Investigator Meeting planning, and works towards first site initiation and first patient enrolled.
Communication is important when working with so many different individuals and teams! When the CTM is able to move the process forward as scheduled and Study Start-Up begins in an organized, efficient manner, the next stage is more likely to continue in that positive direction.
As the study continues, we transition to Maintenance aka Study Conduct. During Maintenance, a Clinical Trial Manager focuses on data integrity, risk management, recruitment and retention, protocol deviations, and provides ongoing training based on study trends.
Maintenance is typically the longest phase and is very important as results are analyzed and metrics are reviewed throughout to ensure the study stays on track. This stage continues until the last patient completes the study.
In study Close-Out, the CTM is responsible for wrapping up the study correctly and efficiently. During Close-Out, the Clinical Trial Manager is accountable for Database Locks, Close-Out visits, and other finalization procedures including the final report to the Institutional Review Board, assisting with the Clinical Study Report draft, final payment reconciliations, and eTMF Closure.
Each stage of a study is important in different ways, and a Clinical Trial Manager needs to be well-versed and prepared to take on what is expected of the role in every stage.
Here is a short video from Dan Sfera, The Clinical Trials Guru, that discusses what a CTM actually does.
What are characteristics of a top-performing CTM?
Clinical Trial Managers are loaded with important responsibilities and they have the ability to make – or break – a clinical trial. Some personality traits may make certain individuals more suitable for this role. The best CTMs often exhibit some of the following characteristics:
- Effective communicator
- Positive leader
These are just some qualities possessed by successful Clinical Trial Managers. What else do you think makes a CTM stand out?
What training is available for Clinical Trial Managers or individuals who want to become a CTM?
When you are hired by a company to be a Clinical Trial Manager or when you are promoted from within, the company may offer training. Often, and especially with the current high-demand for CTMs, you may be expected to jump right in and learn as you go.
The problem is – most CTMs would benefit from more training that will enable them to be more successful in what can be a challenging role!
There is a solution! ClinEssentials offers a CTM Training Course for all levels:
- Experienced CTMs who want to take their career to the next level
- Current CTMs who are struggling with the role and need help
- CRAs or other Clinical Research Professionals who want to become a CTM
- Sponsors or CROs who want to provide training for CTMs to enable them to be successful in their role
The CTM Training Course teaches the key strategies Clinical Trial Managers use to manage their studies from Start-Up to Close-Out. This is CTM training beyond what hiring companies offer, with professional guidance and proven methods to make you confident as a CTM.
Clinical Trial Managers are at the center of each and every clinical trial. Their role is important and meaningful, and carries with it significant responsibility.
If you are a CTM, what do you find most challenging? What could you use additional training on that would help you do your job better? What struggles would you like to overcome to increase your confidence at work?
Please comment below or send an email to email@example.com – we would love to hear from you and we may use your feedback to make the CTM Training Course even better!