Curriculum Builds on Depth of Experience

Alis Vazquez immerses herself in all things clinical research—be it on-the-job learning or a structured, expansive curriculum through our Certificate Program in Clinical Research Conduct and Management.

Her journey started 23 years ago when she first entered the industry as a regulatory coordinator at Teva Pharmaceuticals. And that’s when her deep interest in all aspects of the drug development process was sparked. But rather than continue on a clinical-research associate path, Alis chose to move into project management roles for big-pharma companies. 

“I was being mentored by William Clementi, founder of Clementi and Associates, and he’s become a really good friend of mine,” Alis recalls. “At the time, he was a consultant at Teva Pharmaceuticals. He started training me in project management on how to work on a new drug application. I became so interested in learning how to put all the pieces together.”

And she hasn’t looked back since. I recently had the pleasure of chatting with Alis to learn more about how our clinical research certificate fits in with her deep experience in industry.

Here I am now—23 years into the industry—and I've worked on Phase I through post-marketing trials, across all different therapeutic areas. I have been able to work with pharmaceutical companies, CROs and sites. I have gained a lot of knowledge and experience.

Tell me more about your career trajectory in project management.

After being mentored, I decided to take my career forward and went with Aventis, which is now Sanofi. I started there as a global project planner in 2001. I really started learning about the drug-development process in clinical trials. In my role, I supported project managers on products that were already on the market and those that were going through the new drug application. I supported Phase II through the Phase IV post-marketing studies.

My responsibilities as a global project planner were to manage studies with my cross-functional team members to get a drug to market. During the three years that I spent there, I was able to be a part of two teams that filed electronic Common Technical Documents (CTDs) to the FDA. It was such a great experience.

From there, I branched out to be a clinical project manager on the site side. I started working in Miami at a Phase I-unit site where my responsibilities included running Phase I and Phase II studies. I was able to get the experience from a site perspective as opposed to previously being on the pharmacy side. That also became valuable for me because it just allowed me to continue to grow into the project manager role.

As I moved forward with my industry experience, I started to do contract work as a  project manager for Symcare, Protalex and AstraZeneca. Then I accepted a new position with Spherix Inc. [now Aikido Pharma], a startup company, as director of clinical operations.

In 2012, I joined ProTrials Research as a project manager and worked on infectious-disease trials and oncology.

Here I am now—23 years into the industry—and I've worked on Phase I through post-marketing trials, across all different therapeutic areas. I have been able to work with pharmaceutical companies, CROs and sites. I have gained a lot of knowledge and experience.

For me, what became very interesting and why I chose your certificate is that I was able to do the program from home. The overall program was perfect for me. I started it during the pandemic, and I was so motivated to complete the certificate. I could fit the course into my work/life balance.

You had nearly 20 years of experience before starting our certificate. Why this move?

I have a lot of work experience, but coming to UC Berkeley Extension was a great experience for myself because I wanted to be up to par and earn a certificate that showed that I had completed the clinical research conduct and management curriculum. I've been in the industry long enough to understand the fundamentals and the certificate program offered a structured curriculum to put my experience into perspective.

There are all sorts of certification programs out there in the industry. For me, what became very interesting and why I chose your certificate is that I was able to do the program from home. The overall program was perfect for me. I started it during the pandemic, and I was so motivated to complete the certificate. I could fit the course into my work/life balance.

Were there certain aspects of the certificate that drew you in?

Everything that UC Berkeley Extension teaches in the certificate program is exhaustive. If you want to learn about clinical trials, this certificate program is perfect. It helps you understand the components, how you study startups, the requirements for the FDA, et cetera. You learn about the trial master file. You learn about running clinical trials. Even though I came into the certificate with experience, it was about getting more knowledge and more guidance, and then applying my knowledge from my industry experience.

You also started your own company, ClynProject Consulting.

When I resigned from ProTrials Research, I had been a project manager for six-plus years and decided that I was ready to consult. I felt I had enough knowledge and that clients would be willing to work with me. I was experienced enough to hit the ground running. I started the consulting company in 2017 and got it off the ground in 2018.  Since then, I have been able to work with several clients and have repeat business. 

I also started collaborating with my former mentor at Clementi and Associates. Clementi and Associates provides services to companies that need regulatory consulting, but they have also since then collaborated with me for project management and monitoring.

So, from 2017 until 2022, I was actively consulting. In 2022, I decided that I wanted to take on a full-time job with Catalyst Clinical Research, a company I was already consulting for through my company. I was excited to join them full time and it was such an easy transition because I was already a senior project manager for them.

When looking at the certificate, I knew that it was perfect for me and I’m so happy that I completed it! Now I want to complete the regulatory affairs program.

You made that move only a year after completing our certificate. What does earning the certificate mean to you?

It means a lot because it shows clients that I went through a program, and I have a certificate behind me that supports my professional role as a project manager.

Personally, it means a lot because I always wanted to accomplish it. Early in my career, I was a single mom of three and it was hard for me to take these courses, both because of traveling and the finances. When looking at the certificate, I knew that it was perfect for me and I’m so happy that I completed it! Now I want to complete the regulatory affairs program.

What advice would you give to someone who is just starting the certificate?

Don't be discouraged. Even if you're not coming into the classes with industry experience, it's a great program and it pays off. Having the certificate will give you job placement because it will validate that you took the time to learn about clinical research. And when you get into a position—whether it's a study coordinator, project manager, clinical trial associate or clinical research associate—having this certificate shows that you have educated yourself.

It's really important for anyone who wants to be in this industry to get the certificate— I highly recommend it. For someone like myself who was already in industry and wanted to be a project manager, taking the courses brought me value.