The Race for Better Flu Vaccines: A Clinical Trial Manager's Inside Look

Currently, I am overseeing the Southern Hemisphere portion of a leading Pharmaceutical Influenza vaccination clinical trial. I began this study 2 years ago supporting the United States side of the trial and being a direct contact with sites until last July when I transitioned to overseeing our Southern Hemisphere regions for the same study. My day-to-day varies greatly depending on the study timeline phase we are in but typically many of my roles focused on site communications for various topics, such as enrollment progress, protocol deviation issues, quality event issues, payment oversight, and participant safety. Additionally, I helped create many of our site facing materials for the biweekly newsletters and study coordinator forums.

I started in clinical research under PRA 11 years ago as an IHCRA. After experiencing the CRO side, I wanted to learn the site-facing side as well so I became a clinical research coordinator for a local pediatric hospital. From there, my responsibilities expanded, largely due to the onset of the COVID vaccine trials, and I acted in the role of a study manager, bringing these trials to both pediatric and adult participants in my area. I moved into a manager role overseeing study coordinators but missed the participation in study oversight itself so I joined ICON as a Clinical Trial Manager in 2022.

I love the organized chaotic nature of a clinical research trial. I really enjoyed my time as study coordinator and when my previous employer offered me the opportunity to oversee 2 large COVID trials, I jumped at the chance. From those 2 monumental studies, I realized I really like having what I would consider the best of both worlds – managing and organizing a study, while also being able to maintain the human contact aspect of interacting with the sites and supporting their goals for the study. Clinical Trial Manager offers that balance in many ways and allows me to feel personable with the sites while also being able to see all the moving pieces of the larger picture.

My study’s Project Managers provided me with an opportunity to lead the Southern Hemisphere of our study, after only being with ICON for a year. It was their guidance in learning other country systems, the sponsor’s requirements, and understanding the in’s and out’s of study timeline deliverables that really made me feel successful in this role. Since beginning at ICON, I have always felt empowered to ask any questions I may have related to a task, timeline, or issue the study is facing and have those questions answered with patience and thoroughness. My study team has supported me in taking on a larger role from the beginning of my assignment and as a result, it has really made me feel as though I am a valued member of the team.

I joined ICON as a Clinical Trial Manager in May 2022, working on my first study assignment in July 2022. From there, the Project Managers recognized me for my organizational and leadership skills and offered me the ability to move from overseeing individual sites to providing oversight for the Southern Hemisphere of the study (at the time, 7 countries total). As a result of their trust, I was able to further develop my leadership skills and helped to successfully oversee the study for all of its study timeline activities with the support of my fellow team members.

ICON’s value of inclusion means that every member of the team is valued and their opinions/thoughts are justly heard and incorporated when appropriate. 

Collaboration is key when working on both sides of the study. For our study, it was important to not only collaborate with the site to achieve the deliverables within the timelines but also ensure communication with the sponsor’s site representatives and the sponsor’s project managers themselves in a timely manner. This ensured that everyone had the same picture overall and reduced extraneous communications or mistakes as we recognized we are all on the same team, achieving the same goal. 

ICON’s value of integrity to me means ensuring transparency. Transparent communication with the site puts them at ease that they are successfully contributing to the study. Transparency with the sponsor ensures we are effectively understanding the tasks they wish us to oversee and providing a realistic and accomplishable timeline to achieve their goals. Transparency within the team ensures we are all holding ourselves accountable for our piece of the study to provide a complete and finished product to both the sites and the sponsor. 

I was assigned to a ‘light-speed’ study; the meaning of agility is being able to be flexible with ever-changing timelines and deadlines of deliverables based on the study’s needs. It’s the ability to prioritize effectively within your team to ensure deadlines are met, while also being able to communicate well in advance any potential obstacles with accomplishing the overall goal.

I enjoy that my day-to-day is ever-changing. I feel like my skills for working in a high-paced environment are flexed here often. Changes can occur weekly, daily, or minute to minute depending on the study timeline and deliverable and I enjoy the challenge it brings to prioritize and ensure success of the study. I also appreciate that no two obstacles are ever the same, but often what I learn from addressing one, I can apply to other situations in the future and mentor my colleagues in approaching issues at the same time.

I appreciate the flexibility of my schedule, which allows me to participate and be present for my children’s classroom and extracurricular events. I appreciate the camaraderie nature of working with my fellow coworkers – even though we are working remotely, it doesn’t feel like I’m on an island by myself. Even though I work remotely and rarely travel to meet others assigned to my study, I feel like I have been able to establish wonderful, long lasting relationships with my coworkers as a result of this study.

If you're interested in a pursuing a career in the Clinical Research industry like Megan, view our current vacancies at ICON today.