If I compare a clinical trial to an orchestra, then the Project Manager is the Conductor. Setting the tempo is a special mission which requires knowing the different steps of a clinical study and how to coordinate all the actors by communicating with a simple flick of the wrist!
My orchestra is made up of 25 talented project managers based in Montpellier and Paris. Some of my team members have over 20 years of experience. All of them work on Global Projects for all types of trials – Phases I, II, III, IV and observational studies – but are dedicated to one client. This year, while clinical trials were under the media spotlight, we were particularly proud to give our all to develop Covid-19 studies.
We can intervene at every step. On a full-service trial, we start by examining the existing draft protocol and then make recommendations to enhance its effectiveness. We determine feasibility, i.e. in which country and at which site the trial should take place to deliver the protocol within the given timeframe. We initiate the chosen site by training staff and beginning enrollment. Then we monitor the protocol’s progress, manage patients and crunch the data for the trial master file. Finally, we close out the study and notify regulatory bodies if necessary.
Things move quickly in clinical trials. To make sure we adapt just as quickly, we are always trained on new processes. We take time to share our knowledge, and to help each other during informal meetings (especially our aptly named e-café). We also nominate one team expert for different subject matters, who is our knowledge point person and can be consulted at any moment.
As the Head of this Project Manager unit, I ensure that we are on track for reaching clinical trials objectives, by catching up with the team and the clients, putting in place mentoring & training, and finding solutions to every question. During a typical day, I also keep time for training myself, discussing future needs for our client, meeting new candidates, and onboarding newcomers to the team! I love to manage different topics at once, to ensure the best quality for our clinical trials and to conduct our ensemble to a perfect translation of the underlying music.